Podcasts about Biosimilar

Though India has built a robust domestic biosimilar market, its international presence and the ability to lower prices as compared to small molecule generics remain limited.  

This special vodcast series provided by The Center for Biosimilars® was developed in partnership with the AAM and Biosimilars Council. Check out part 1 of the series featuring a discussion between Giuseppe Randazzo and Craig Burton, former executive director of the Biosimilars Council and current senior vice president of government affairs and policy at Fresenius Kabi. References Jeremias S. The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars. February 5, 2025. Accessed May 3, 2025. https://www.centerforbiosimilars.com/view/the-biosimilar-void-90-of-biologics-coming-off-patent-will-lack-biosimilars

New indication for Kerendia; investigational therapy shows promise for hypertension; Novolog interchangeable biosimilar gets approval; trial results for hormone-free contraceptive; Shingrix now supplied in a prefilled syringe.

In today's episode, supported by Camber Pharmaceuticals, we spoke with Kanwarpal S. Kahlon, MD, an associate clinical professor of medicine at the UCLA School of Medicine. In our exclusive interview, Dr Kahlon discussed the significance of the commercial availability of the generic, AB-rated formulations of eltrombopag (Promacta), a bioequivalent medication for the treatment of select patients with severe aplastic anemia and immune thrombocytopenia. He noted how the biosimilar is expected to reduce costs and improve the accessibility of this treatment, potentially enhancing patient adherence. He also explained how it is available in both oral suspension and tablet formulations and that it is well tolerated, with a safety profile similar to that of the original drug.

A new epinephrine nasal spray dosage has been approved for pediatrics; FDA agree to review Semaglutide for weight management; A wearable defibrillator is cleared to prevent sudden cardiac arrest; a low dose formulation of chlorthalidone is approved to treat hypertension; and Selarsdi is now interchangeable with Stelara.

This Day in Legal History: President Lincoln DiesOn this day in legal history, April 15, 1865, President Abraham Lincoln died from a gunshot wound inflicted the night before by actor and Confederate sympathizer John Wilkes Booth. The assassination occurred at Ford's Theatre in Washington, D.C., where Lincoln was watching a play with his wife. He was shot in the back of the head and never regained consciousness, dying the next morning at 7:22 a.m. His death was the first assassination of a U.S. president and triggered a constitutional transition of power during a critical moment in American history. Vice President Andrew Johnson was sworn in the same day, inheriting the enormous task of leading the country through the fragile early stages of Reconstruction.Legally, Lincoln's assassination set several precedents. It led to the use of military tribunals to try civilians involved in Booth's conspiracy, a decision that remains controversial in constitutional law. The event also underscored the importance of presidential succession, later clarified by the 25th Amendment. In the immediate aftermath, martial law and curfews were imposed in the capital, and a massive manhunt ensued for Booth and his co-conspirators. The killing intensified public sentiment against the South and complicated efforts to reunify the nation. Johnson's approach to Reconstruction diverged sharply from Lincoln's more conciliatory plans, shaping decades of legal and political conflict over civil rights. The assassination deeply impacted how the federal government approached both national security and executive protection. The tragedy marked not just the loss of a president, but a shift in the legal and political structure of post-Civil War America.As Lincoln's funeral train retraced the route that had carried him from obscurity in Illinois to the presidency, it served as a symbolic farewell to both the man and the future he might have shaped. Each stop along the way—cities draped in mourning, crowds in silent grief—marked not only the end of his political journey but also the shunting off of a potential trajectory for his second term. Had Lincoln lived, his vision for a more lenient and reconciliatory Reconstruction might have softened the bitter divisions that would later deepen under Andrew Johnson's combative leadership. Perhaps civil rights protections would have been implemented sooner, with Lincoln using his political capital and moral authority to push for more lasting equality. The possibility remains that a different course could have been taken—one that prioritized unity without compromising justice, and that may have led to a more inclusive and less violent post-war America.Kilmar Abrego Garcia, a legally residing Salvadoran migrant in Maryland with a U.S. work permit, was wrongly deported to El Salvador in March, despite a judge's order blocking his removal. The Trump administration acknowledged the deportation was in error but has told a federal court it is not obligated to help him return from prison in El Salvador, interpreting a Supreme Court directive to "facilitate" his return as limited to removing domestic barriers—not assisting with his release abroad. A U.S. District Court judge had ordered the government to bring him back, a decision the Supreme Court upheld by rejecting the administration's appeal. However, a top immigration official has now argued the deportation order is moot, citing Abrego Garcia's alleged ties to MS-13, a group newly designated as a foreign terrorist organization. The State Department has confirmed that Abrego Garcia is "alive and secure" in a terrorism detention facility in El Salvador. Legal efforts continue, with Abrego Garcia's attorneys seeking more information from the government. The administration warns this could disrupt diplomatic talks, particularly with El Salvador's President Nayib Bukele visiting Washington. President Trump has said his administration would comply if ordered directly by the Supreme Court.Trump administration says it is not required to help wrongly deported man return to US | ReutersSandoz, a Swiss generic drugmaker, has filed a U.S. antitrust lawsuit against Amgen, accusing it of unlawfully maintaining a monopoly on its arthritis drug Enbrel. The lawsuit, filed in federal court in Norfolk, Virginia, alleges that Amgen created a "thicket of patents" to block the entry of biosimilar competitors like Sandoz's Erelzi, which has been approved by the FDA since 2016 but has not launched in the U.S. Sandoz claims this strategy has kept its lower-cost alternative off the market, depriving patients of affordable options and causing the company to lose millions in potential monthly sales. Amgen has not yet commented on the lawsuit. Enbrel generated $3.3 billion in U.S. revenue in 2024 alone and is used to treat inflammatory diseases such as rheumatoid arthritis. Sandoz argues that Amgen's patent practices violate federal antitrust laws by suppressing competition and artificially extending its market dominance. The company is seeking an injunction to stop Amgen from using its patent portfolio in this way, as well as financial damages for lost sales.Sandoz files U.S. antitrust lawsuit against Amgen over arthritis drug | ReutersThe U.S. Government Accountability Office (GAO) has agreed to investigate recent changes at the Securities and Exchange Commission (SEC), including those influenced by the White House and the Department of Government Efficiency (DGE), led by Elon Musk. This probe follows a request from Senators Elizabeth Warren and Mark Warner, who raised concerns about the SEC's ability to fulfill its regulatory duties amid sweeping restructuring efforts. Since President Trump's return to office and the Republican takeover of the agency, the SEC has reduced staff, ended leases, and reorganized operations. It has also scaled back enforcement efforts and seen a wave of resignations as part of a broader federal downsizing initiative. The GAO confirmed that the request for an investigation falls within its authority, with the review expected to begin in about three months. Lawmakers stress the importance of understanding how these changes may be undermining the SEC's mission. The agency's funding, while approved by Congress, is sourced from transaction fees rather than taxpayer dollars. These developments coincide with market instability triggered by Trump's recent tariff announcement.US congressional watchdog to probe changes at the SEC, letter says | Reuters This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.minimumcomp.com/subscribe

Guest: Andre Harvin, PharmD, MS, MBA Biosimilars have greatly impacted the US healthcare system over the last decade, creating cost savings and increasing access for patients.1,2 However, although some biosimilars have seen significant adoption, not all biosimilars have been able to achieve sustainable market use.1 Learn about the barriers to biosimilar adoption in the US and strategies for overcoming them from Dr. Andre Harvin. Dr. Harvin is the chief pharmacy officer at Cone Health in Greensboro, North Carolina. References: AAM, The U.S. Generic & Biosimilar Medicines Savings Report, September 2023 IQVIA Institute for Human Data Science, Biosimilars in the United States 2023-2027: Competition, Savings, and Sustainability, January 2023 © Fresenius Kabi USA, LLC 2025 03/2025

First Xolair biosimilar approved, Wearable furosemide loop diuretic gains expanded indication; Implant approved for macular telangiectasia; Novel treatment shows promise in hypertension; And testing reveals high benzene levels in over-the-counter acne treatments.

Generics Bulletin editors Dave Wallace and Dean Rudge discuss the latest updates on Stelara (ustekinumab) biosimilars in the US, including recent launches, pricing strategies, and parallels with the biosimilar Humira (adalimumab) experience.

 Show notes  To learn more about the 10th anniversary of the first FDA biosimilar approval, click here.  To learn more about how much biosimilars have saved so far, click here.  To read more about Josh's views on the pharmaceutical landscape in 2025, click here. 

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: New drug is looked at for T1D prevention, a new stem cell method is tested for beta cell transplanation without immunosuppresion drugs, the FDA okays the first fast-acting biosimilar insulin, Lilly lowers price of Zepbound, and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links:   Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX New research in type 1 diabetes prevention launches. Nektar Therapeutics and TrialNet will evaluate a drug currently used for exzema for patients with new onset stage 3 type 1 diabetes The drug is RezPeg – that's a shortened version of the name (rezpegaldesleukin)   This will be a study of about 70 adults and children and will launch this year. The new study will use a mixed meal tolerance test (MMTT) to measure the efficacy of rezpegaldesleukin or placebo for preserving C-peptide area under the curve over a 12-month duration comprised of a 6-month treatment period and a 6-month follow-up. Secondary objectives include pharmacokinetics, pharmacodynamics, and additional disease assessments including HbA1c levels and patient insulin requirements. Rezpegaldesleukin is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases. https://www.prnewswire.com/news-releases/nektar-announces-clinical-trial-agreement-to-evaluate-rezpegaldesleukin-in-patients-with-new-onset-type-1-diabetes-mellitus-302383052.html XX NLS Pharmaceutics (NLSP) and Kadimastem announced successful completion of a pre-IND meeting with the FDA for iTOL-102, a potential diabetes treatment. iTOL-102 combines Kadimastem's IsletRx cells (stem cell-derived pancreatic islets) with iTolerance's immunomodulator iTOL-100, aiming to cure Type 1 Diabetes without requiring life-long immune suppression. The treatment was evaluated at the Diabetes Research Institute at the University of Miami School of Medicine, where it demonstrated functional insulin release and disease reversal in animal models. Based on FDA feedback, the companies are updating plans for safety toxicology studies and First-in-Human clinical trials. IsletRx is a clinical-grade product comprising human pancreatic islet-like cells capable of secreting insulin, offering a scalable source of insulin-producing cells to address donor islet shortages. The technology can detect glucose levels and produce required amounts of insulin and glucagon.   XX FDA has signed off on a rapid-acting insulin biosimilar for the first time. The agency has given a thumbs up to Sanofi's Merilog (insulin-aspart-szjj) as the first biosimilar to Novo Nordisk's NovoLog for patients with diabetes. Merilog will be provided by prefilled pen in a 3 mL dose or in a multiple-dose 10 mL vial. It is for adults and pediatric patients age 6 and older.     NovoLog and Novo Nordisk's other rapid-acting insulin follow-on Fiasp are among the drugs subject to government price negotiations under the Inflation Reduction Act. The new prices will be enacted at the start of next year. In July 2021, the FDA approved Biocon and Viatris' Semglee (insulin glargine-yfgn) as the first biosimilar to Lantus. Five months later, the U.S. regulator endorsed Eli Lilly's version of the drug, called Rezvoglar (insulin glargine-aglr). https://www.fiercepharma.com/pharma/fda-signs-sanofis-biosimilar-first-novo-nordisks-rapid-acting-novolog XX Eli Lilly said Tuesday that it will offer more doses of its obesity drug Zepbound in vials and lower the prices of the doses it already sells, as the pharma giant seeks to draw patients away from cheap, compounded copies of weight loss medications. The company launched 7.5 mg and 10 mg vials of tirzepatide, sold under the brand name Zepbound, which typically cost $599 and $699, respectively. However, they are now available for $499 per month for patients paying without insurance. This applies to the first fill and all refills that are delivered every 45 days. Additionally, the company lowered the prices of the 2.5 mg and 5 mg vials to $349 and $499 per month, respectively. The company, which has seen a significant boost in profits from Zepbound and Mounjaro – essentially the same drug with different FDA-approved uses – announced that the new vials and pricing are exclusively available through the company's self-pay pharmacy, LillyDirect Self Pay Pharmacy Solutions. https://www.bloomberg.com/news/articles/2025-02-25/zepbound-cost-for-vials-cut-to-battle-cheaper-copycats XX Medicare spending on 10 diabetes drugs, including popular GLP-1s, more than quadrupled over a five-year period and could reach $102 billion next year, an analysis by Health and Human Services' inspector general found. The findings also come as the Trump administration weighs the fate of a Biden administration proposal that would require Medicare and Medicaid to cover GLP-1s for weight loss. The biggest spikes in usage were for Rybelsus, Novo Nordisk's once-daily GLP-1 tablet, and for the company's weekly injectable Ozempic, whose spending about doubled every year under review. https://www.axios.com/2025/02/25/medicare-spending-surge-diabetes-drugs XX Tandem Diabetes Care has secured a new FDA clearance for its insulin dose-calculating algorithm, opening up Control IQ for use in adults with Type 2 diabetes. The expanded label was based on data from a pivotal, randomized trial of more than 300 people with Type 2 diabetes, comparing its use to manual multiple daily injections. Tandem said it plans to present the study's results at the annual Advanced Technologies & Treatments for Diabetes meeting scheduled for next month in Amsterdam. https://www.fiercebiotech.com/medtech/tandem-diabetes-care-insulin-dosing-algorithm-nets-fda-clearance-type-2-diabetes XX Drugs approved for diabetes and obesity might be useful for the treatment of cognitive and mental health disorders, according to a new paper published in Nature Mental Health.   The study reviewed and integrated data from both preclinical and clinical studies to gather evidence on the possible effects of these drugs GLP1s and semaglutide  in conditions such as dementia, substance use disorders, psychotic disorders, mood and anxiety disorders, and eating disorders.     The study found promising but still preliminary evidence that GLP-1RAs could be beneficial over a range of cognitive and mental health disorders. These drugs have shown potential in improving cognition, reducing addictive behavior, and alleviating depression and anxiety. More data from robustly designed studies (i.e., randomized controlled trials) are needed to better understand GLP-1RAs' prospective efficacy and safety profile, especially with long-term use. https://medicalxpress.com/news/2025-02-diabetes-drugs-mental-health-treatment.html XX The FDA  issued draft guidance that includes recommendations to support the development and marketing of safe and effective AI-enabled The guidance, if finalized, would be the first guidance to provide comprehensive recommendations for AI-enabled devices throughout the total product lifecycle, providing developers with an accessible set of considerations that tie together design, development, maintenance, and documentation recommendations to help ensure the safety and effectiveness of AI-enabled devices. FDA is requesting public comment on this draft guidance by April 7. The agency also released draft guidance for the use of AI to support regulatory decision-making for drug and biological products. https://www.mddionline.com/artificial-intelligence/fda-issues-draft-guidance-for-ai-enabled-devices-seeks-public-feedback XX Congrats to Mila Clarke who some of you may know better as Hangry Woman on social. She has developed a great app called Glucose Guide and the Nutrition Assistant portion of that app went live this week. Glucose Guide is a web and mobile app that offers diabetes meal tracking, coaching, resources, recipes and community to those looking for help managing diabetes. MEAL AND BLOOD SUGAR TRACKING FEATURES.

New vaccines to protect against meningococcal disease and chikungunya virus; skin prep product recalled due to fungal contamination; rapid-acting insulin biosimilar approved; and twice-yearly lenacapavir gets FDA's priority review for HIV PrEP.

In the latest episode of IBX: The Cover Story, guest host Dr. Reetika Kumar, SVP & Chief Customer Product, Clinical Solutions & Pharmacy Services at IBX is joined by Helen Sherman, Chief Transformation Officer at Evio and Julie Bartl, President of Employee Benefits at Johnson, Kendall & Johnson to discuss our recent Humira biosimilar launch and the unique approach we took to ensure cost savings while maintaining high quality for our clients and members.  

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Takeda, Roche, and Gilead have recently made significant deals in the pharmaceutical industry. Takeda's investment of up to $1.3 billion in Keros' blood cancer anemia drug is making waves, potentially challenging Bristol Myers Squibb. Roche has joined forces with Cour in a deal focused on autoimmune diseases, valued at over $900 million. Meanwhile, Gilead is reentering the ADC space with a potential $415 million license agreement.In other news, Intra-Cellular is seeking approval for Caplyta in major depressive disorder, a move that could result in $1 billion in sales. Unfortunately, Alligator has been forced to reduce its staff by 70% due to capital constraints. On a brighter note, Biocon has received FDA approval for a biosimilar to J&J's Stelara, and Applied Therapeutics is making strides in the fight against deadly brain cancer.However, Bluebird's gene therapy Skysona is currently under FDA safety probe for hematologic malignancies, raising concerns within the industry. Despite this setback, the pharmaceutical industry as a whole continues to see growth and innovation on multiple fronts.

Alongside Cochrane Reviews of the effects of original drugs for the treatment of some diseases, reviews are starting to appear of the effects of biosimilars for these drugs. In this podcast, Roses Parker, Cochrane's Commissioning Editor tells us about the evidence in one of these reviews, published in November 2024, which considers biosimilar monoclonal antibodies for the treatment of patients with cancer.

Alongside Cochrane Reviews of the effects of original drugs for the treatment of some diseases, reviews are starting to appear of the effects of biosimilars for these drugs. In this podcast, Roses Parker, Cochrane's Commissioning Editor tells us about the evidence in one of these reviews, published in November 2024, which considers biosimilar monoclonal antibodies for the treatment of patients with cancer.

Show notes To learn more about GBW, click here. To check out our coverage of the recent GRx+Biosims conference Craig mentioned, click here. To learn more about product hopping, click here. To read part 1 of our GBW series, click here. To read part 2 of our GBW series, click here. To read part 3 of our GBW series, click here. To hear another episode featuring more of Craig's thoughts on the Biden's administration's impact on the biosimilar industry, click here.

Subscribe to UnitedHealthcare's Community & State newsletter.Health Affairs' Editor-in-Chief Alan Weil interviews Janice Jhang of Harvard University about her recent paper that explores how regulatory and market forces are driving adoption of biosimilars.Order the November 2024 issue of Health Affairs.Currently, more than 70 percent of our content is freely available - and we'd like to keep it that way. With your support, we can continue to keep our digital publication Forefront and podcasts free for everyone. Subscribe to UnitedHealthcare's Community & State newsletter.

Today, we are exploring a fascinating topic: how real-world data is reshaping the landscape of biosimilars. Dr. Russell Robbins, Chief Medical Information Officer and Dr. Diane Faraone, Senior Director in Pharmacy Analytics, will be discussing how real-world data is not only advancing the development and adoption of biosimilars but also improving access to these vital therapies. So, whether you're a healthcare professional, a patient, or simply curious about the future of medicine, stay tuned for an insightful conversation on the power of data in modern healthcare.

Health Affairs' Editor-in-Chief Alan Weil interviews Dongzhe Hong of Brigham and Women's Hospital and Harvard University on his recent paper that explores how patient and prescriber factors play into biosimilar uptake in the US.Order the August 2024 issue of Health Affairs.Currently, more than 70 percent of our content is freely available - and we'd like to keep it that way. With your support, we can continue to keep our digital publication Forefront and podcasts free for everyone.

Show notes 1. FDA Approves Samsung Bioepis' Pyzchiva, a Biosimilar to Stelara 2. Ahzantive Receives FDA Approval as New Eylea Biosimilar 3. FDA Approves Epysqli as Second Soliris Biosimilar 4. BioRationality: Time to Get Rid of PBMs if Biosimilars Are to Succeed 5. Biosimilars and Employers: Strategies for Success 6. Learning the Lingo of Biologics and Biosimilars Is Critical 7. Singapore Experience Shows Benefits of Value-Driven Strategies in Generating Biosimilar Savings 8. Approximately Half of Patients Demonstrated Poor Health Literacy Prior to Biosimilar Switch

Duchenne muscular dystrophy treatment now available; Noise therapy wearable for nasal congestion; Treatment for delaying diabetes gets Fast Tracked; Soliris biosimilar approved; And the first orally-disintegrating contraceptive.

This rule-based informatics solution pulls from the electronic health record to automate the election of an appropriate biosimilar therapy based on the patient's insurance and hospital formulary preferences, streamlining prior authorization and approval processes. This e-tool decreased administrative burden to providers, pharmacists, and prior authorization specialists and increased biosimilar utilization by 21.9%. Guest: Sarah Hudson-DiSalle, PharmD, RPh, FACCC Assistant Director of Reimbursement Services The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute   “Using an EHR auto-selection tool that takes into consideration insurance preferences and contractual relationships to provide a proactive solution has helped our providers, our pharmacists, and our prior authorization specialists.”   Hear more about this innovation at the ACCC 41st National Oncology Conference, October 9-11, 2024, in Minneapolis, Minnesota.   Resources: Biosimilars Implementation Roadmap [MINI PODCAST] Ep 103: Precision Medicine: Robots, Biologics, and Advocates: Lessons from the Pharmacy Improve Oral Oncolytic Workflow and Reduce Treatment Delays with a Pharmacist Collaborative Practice Agreement Shifting Chemo Administration from Inpatient to Outpatient Setting Improves Care and Reduces Costs Reducing Revenue Loss and Patient Financial Toxicity with Pharmacy Pre-Certification and Denials Management [PODCAST] Ep 39: Biosimilars—What Patients Need to Know

Am kommenden Sonntag wird in Europa gewählt. Jede und jeder ab 16 Jahre sollte mitmachen. Die beiden Wirtschaftsjournalisten Dietmar Deffner und Holger Zschäpitz debattieren über die streitentscheidenden Wirtschaftsthemen der EU und verraten, welche Parteien bei ihnen ganz oben stehen. Weitere Themen: - Aktionärsvotum bei Tesla – Wer kann in Deutschland für oder gegen Musk stimmen? - Aktionärsvotum bei Tesla – Wer kann in Deutschland für oder gegen Musk stimmen? - Pleite beim Touristikkonzern FTI – Welche Aktie jetzt durchstarten könnte - Biosimilar vs Generika – Was sind die Unterschiede und welche Aktie hat Potenzial - Wahlwirren in Mexiko und Indien – welche Risiken die Schwellenländeraktien bergen und warum Wirtschaftswachstum kein Garant für steigende Börsen ist Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutzerklärung: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html

Extended-release ADHD treatment gains approval; An interchangeable biosimilar to Soliris is approved; Investigational treatment shows promise for improving depression and insomnia; The FDA vote on a blood-based colorectal cancer diagnostic; Survey reveals public attitudes towards the FDA.

Show notes To read our coverage of the Cardinal Health report, click here. To read the full report, click here. To check out The Center for Biosimilars coverage of Festival of Biologics USA, click here.

Today's show discussed biosimilar development from a clinical pharmacology perspective. I describe what biosimilar products are and the necessary comparisons to the reference product. I review requirements for PK similarity, PD similarity, immunogenicity, and safety. I also touch on the idea of interchangeability between the biosimilar and reference products. Links discussed in the show: FDA Guidance on Clinical Pharmacology Data to support Biosimilarity (May 2016) FDA Guidance on Demonstrating Interchangeability (May 2019) FDA Q&A on Biosimilarity and Interchangeability (Sep 2023) You can connect with me on LinkedIn and send me a message Send me a message Sign up for my newsletter Copyright Teuscher Solutions LLC All Rights Reserved

Since a number of biosimilars to Humira became available in 2023, many more arthritis patients have become aware of these drugs, and many are being required by insurance to switch to one. In this episode, a patient and a rheumatologist will discuss their experience with biosimilars and how they are addressing concerns. *Visit the Live Yes! With Arthritis Podcast episode page to get show notes, additional resources and read the full transcript: https://arthr.org/LiveYes_Ep103 (https://arthr.org/LiveYes_Ep103) * We want to hear from you. Tell us what you think about the Live Yes! With Arthritis Podcast. Get started by emailing podcast@arthritis.org (podcast@arthritis.org). Special Guests: Dr. Angus Worthing and Rick Phillips.

Pink Sheet reporter and editors discuss the impact of FDA biosimilar promotion guidance on the future of the interchangeability designation (:34), upcoming guidance on accelerated approval for gene therapies (14:15), and partisan attacks on the agency from Capitol Hill (27:13). More On These Topics From The Pink Sheet Rx Advertising: Interchangeability Doesn't Mean Clinical Superiority To Other Biosimilars, FDA Says: https://pink.citeline.com/PS150143/Rx-Advertising-Interchangeability-Doesnt-Mean-Clinical-Superiority-To-Other-Biosimilars-FDA-Says US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets' Of Use Scenarios: https://pink.citeline.com/PS150140/US-FDA-Gene-Therapy-Accelerated-Approval-Guidance-Will-Describe-Buckets-Of-Use-Scenarios Partisan Politics Returns To US FDA Congressional Oversight: https://pink.citeline.com/PS150114/Partisan-Politics-Returns-To-US-FDA-Congressional-Oversight

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. The FDA recently approved a biosimilar of Stelara from Alvotech and Teva, set to launch early next year. Johnson & Johnson reported mixed sales performance for new multiple myeloma drugs, with Tecvayli sales exceeding expectations and Carvykti underperforming. Roche also released survival data for a new lymphoma drug, potentially giving it an edge over a competitor. The US government sued Regeneron for allegedly falsely reporting prices on the blockbuster eye drug Eylea. Other topics covered in the newsletter include drug pricing trends, diversity in clinical trials, and the weight loss drug market.In order to successfully execute health advertising campaigns, marketers need to take a proactive approach by targeting health audience segments online. Actionable insights are provided to maximize the impact of media investment through tips such as implementing a test and learn strategy, scaling results quickly, and asking tough questions to potential health targeting partners. Veeva Crossix is highlighted as a company that implements these tactics to reach consumers throughout the patient journey.Abbott CEO Robert Ford highlighted new and upcoming products during an earnings call, emphasizing the recently approved Triclip valve as a significant opportunity for growth. The FDA issued a warning to Soulaire for selling a device outside of authorized uses. Lilly's obesity drug showed benefits in a sleep disorder study, indicating potential new uses. Johnson & Johnson's $30 billion spending spree on companies like Abiomed, Laminar, and Shockwave Medical may continue. Additionally, Philips entered into a consent decree with the FDA, where the agency will use rare powers to require repairs, replacements, or refunds for recalled respiratory machines.Eli Lilly's weight-loss drug Zepbound has shown effectiveness in treating sleep apnea, leading the company to prepare for a label expansion. Amylyx faced a setback with the failure of its ALS drug Relyvrio, leading to layoffs and market withdrawal. Despite this, the company saw success in treating Wolfram syndrome. Sage Therapeutics also announced the discontinuation of its Parkinson's disease program after disappointing results in phase II trials, shifting focus to Huntington's and Alzheimer's diseases.The medical device industry is increasingly incorporating AI and digital health technologies to improve performance and outcomes. Overall, the medtech sector is evolving rapidly with new products and technologies driving growth and innovation.

Biosimilars are entering the market at their fastest pace ever. In this episode, we interview a renowned health economist and an expert consultant in biosimilar distribution and patient support to explore the complex landscape of biosimilars, including examining the hurdles and breakthroughs in achieving acceptance by payers and providers and how best to improve patient access and affordability in a market dominated by established brands. Dr. Jason Shafrin, Senior Managing Director, Center for Healthcare Economics and Policy at FTI Consulting Marina Allen, SVP, Fingerpaint Market Access, Patient Support & Access Strategy Leader in Pharma-Biotech Biosimilars The Biologics Price Competition and Innovation Act of 2009 PBMs (Pharmacy Benefit Managers) Medicare Advantage Humira (biosimilars) 340B program Inflation Reduction Act Medicare Part D "brown bagging and white bagging" Mark Cuban (CostPlusDrugs) GoodRx average sales price (ASP) electronic health record (EHR) system Questions or comments?Email us at comments@prescriptionforbetteraccess.com.Find us on social media! Follow us on X, LinkedIn, YouTube and Threads.

For more information on BsUFA III, click here. For more information on the 1-year anniversary of adalimumab biosimilars in the US, click here. To listen to more of Julie Reed's thoughts on the US biosimilar industry and streamlining development, click here.  To learn more about the Biosimilars Forum, click here.

Happy Birthday Adalimumab Biosimilars: Reflecting on the First Year of US Competition EMA Approves First Ustekinumab Biosimilar, Uzpruvo Eye on Pharma: Fresh Biosimilar Lawsuits; FDA to Review Ustekinumab, Denosumab Biosimilars IQVIA Report Flags Challenges With Biosimilar Access, Savings Throughout Europe IQVIA Projects $192 Billion Loss for Originators by 2028 Thanks to Biosimilar, Generic Competition Report: Varied Biosimilar Uptake Speeds Pose Missed Opportunities for Cost Savings Biosimilar SB5 Matches Originator in Safety, Efficacy for Inflammatory Diseases After Switching Postapproval Pharmacovigilance Review Confirms Comparable Safety Between Sandoz Biosimilars, Originators

It's no secret that pharmaceutical manufacturers and payers don't always see eye to eye.But in order for pharma market access to do its job it needs to better understand payers -- how  they think, what keeps them up at night, and what's trending.That's why Valuate conducted its Second Annual Market Access survey late last year. The goal was to better understand payer perspectives on everything from the Inflation Reduction Act to biosimilars to gold bagging. Tony Gibson, a Principal with Valuate Health, returns to The IDI to break down the results. You can also contact Tony if you want an exclusive readout of the survey.Follow Tony on  LinkedIn. Follow Valuate on LinkedInLearn more about Valuate.

As many new adalimumab biosimilars have been hitting the market, three experts discuss current market trends and how their organizations are projecting the future impact of these biosimilar products. During this podcast, speakers discuss modeling strategies, planning for resources, and operational changes needed to support biosimilar adoption. The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.

If you remember your Economics 101 class, the introduction of generic and biosimilar drugs should cause prices to drop. Yet, when it comes to MS disease-modifying therapies that isn't always the case.  MS Navigator Robin LaRue joins me this week to discuss how to manage the sometimes crazy costs of MS prescription medications. We're also sharing results from a study that show there is absolutely no association between consuming dairy and gluten products and MS disease activity. We'll tell you about two different studies that suggest that non-pharmaceutical interventions may be effective in lessening MS fatigue. We're sharing results from a trial that reveal an innovative approach to supporting MS caregivers. And we'll tell you about 4.6 million euro in new funding from the International Progressive MS Alliance that will go toward research focused on developing new treatments for progressive MS. We have a lot to talk about! Are you ready for RealTalk MS??! This Week: Managing the cost of MS medications  :22 STUDY: No association between consuming dairy and gluten products and MS disease activity  1:42 STUDY: SMS-messaging is shown to improve MS-related fatigue  4:50 STUDY: Talk therapy is shown to improve MS-related fatigue  8:36 STUDY: Remote coaching and online information improves the well-being of MS caregivers  10:43 International Progressive MS Alliance announces new research funding  13:32 MS Navigator Robin LaRue discusses how to manage the cost of MS prescription medications   15:57 Share this episode  27:48 Have you downloaded the free RealTalk MS app?  28:09 SHARE THIS EPISODE OF REALTALK MS Just copy this link & paste it into your text or email: https://realtalkms.com/332 ADD YOUR VOICE TO THE CONVERSATION I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts! Email: jon@realtalkms.com Phone: (310) 526-2283 And don't forget to join us in the RealTalk MS Facebook group! LINKS If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com STUDY: Dairy and Gluten in Disease Activity in Multiple Sclerosis https://journals.sagepub.com/doi/10.1177/20552173231218107 STUDY: Text Messaging Intervention for Fatigue Self-Management in People with Stroke, Spinal Cord Injury, and Multiple Sclerosis: A Pilot Study https://sciencedirect.com/science/article/abs/pii/S1936657423001310?via%3Dihub STUDY: Effectiveness of a Blended Booster Programme for the Long-Term Outcome of Cognitive Behavioural Therapy for MS-Related Fatigue: A Randomized Controlled Study https://journals.sagepub.com/doi/full/10.1177/13524585231213258 STUDY: Effect of 2-Arm Intervention on Emotional Outcomes in Informal Caregivers of Individuals with Multiple Sclerosis: A Randomized Pilot Study Trial https://meridian.allenpress.com/ijmsc/article/25/6/252/495534/Effect-of-2-Arm-Intervention-on-Emotional-Outcomes International Progressive MS Alliance https://progressivemsalliance.org Join the RealTalk MS Facebook Group https://facebook.com/groups/realtalkms Download the RealTalk MS App for iOS Devices https://itunes.apple.com/us/app/realtalk-ms/id1436917200 Download the RealTalk MS App for Android Deviceshttps://play.google.com/store/apps/details?id=tv.wizzard.android.realtalk Give RealTalk MS a rating and review http://www.realtalkms.com/review Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com. RealTalk MS Episode 332 Guest: Robin LaRue Privacy Policy

Show notes To learn more about the prospect for Neulasta OnPro biosimilars, click here. To learn more about how the IRA will impact biosimilars, click here.  To learn more about the dual-pricing strategy being used for adalimumab biosimilars, click here. To hear Brian's insight into how the ophthalmology biosimilar industry is developing, click here. To listen to previous Not So Different episodes featuring more of Brian's insight into how the adalimumab market will develop and biosimilar pricing trends, click here or here.

Are the many new biologic drugs that launch each year bringing the clinical innovation that patients desperately need or the financial doom that healthcare benefit plan sponsors and their members cannot afford?  Or both?  What are biosimilar drugs and how can they help?  This podcast and its related series of articles in Health Watch helps actuaries better understand the potential clinical and financial impact that the coming wave of biosimilars could have on our healthcare system and how plan sponsors can best leverage it for their populations.

 Show notes Webinar: Where Do Biosimilars Fit Into the Cancer Treatment Puzzle? Part 1: Oncology Biosimilars Offer Comparable Benefits to Originators at Lower Prices Part 2: French Study Finds Trastuzumab Biosimilar Program Could Generate Meaningful Savings Part 3: Study Questions Usefulness of Clinical Efficacy Trials for Oncology Biosimilars in Europe Denosumab Biosimilar Demonstrates Positive Safety Results in Chinese Study Eye on Pharma: Denosumab Biosimilar Data; COA Forms New Committee; IGBA and WHO Collaborate Similar Safety Profiles of Biosimilar, Reference Pegfilgrastim Found in Clinical Studies Study: Biosimilar Use, Dose Rounding Produce More Cost Savings Than Either Strategy Alone

Humira Biosimilar Landscape Other platforms Apple Podcasts -   https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836 Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/ Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67

FDA Approves First Subcutaneous Infliximab Product Abrilada Approved as Second Interchangeable Humira Biosimilar Eye on Pharma: New GI Data and Byooviz Interchangeability Propel Biosimilars Into the Future Biosimilars Check-In: BI Launches Unbranded Adalimumab; New Omalizumab Deal; CRL for Insulin Aspart Eye on Pharma: Another CRL for Alvotech; Cimerli's Growing Market Share; BBCIC Awarded Grant Samsung Bioepis Presents Positive Phase 3 Data on Aflibercept Candidate AMCP Nexus: Panelists Share Current Scope of Biosimilar Industry

Biosimilar Medications and MS: What You Need To Know - Episode 155 - Transcript - Biosimilars are not new to the medical world, but they are new to multiple sclerosis. In this episode, host Stephanie Buxhoeveden welcomes neurologist Derrick Robertson to talk about what you need to know about biosimilar medications as they come to market. Join us for this conversation, and you'll get answers to common questions like: what is a biosimilar? What are the differences between biosimilars vs. generics? What is the biosimilar approval process? Are biosimilars safe? And what questions you should be asking your doctor. Thank you to Sandoz for their support of this podcast episode.   Disclaimer: This podcast provides general educational information. Can Do MS does not endorse, promote, or recommend any product or service associated with the content of this program.  

Just a couple of weeks ago, the FDA approved the first biosimilar medication for treating MS. As generics and now, biosimilars, become more available, it seems like the right time for us to get clear on the similarities and differences between generics, biosimilars, and the name-brand drugs that they mimic.  Dr. Jiwon Oh joins me to explain everything you need to know to be an informed medical consumer when it comes to generic and biosimilar disease-modifying therapies. Dr. Oh is a neurologist, scientist, and the Medical Director of the Barlo Multiple Sclerosis Program at St. Michael's Hospital in Ontario. We'll also tell you about a simple blood test that can measure MS disease activity.  Izzy Abbas, the Co-Chairperson of the Paralyzed Veterans of America MS Committee will explain how the PVA supports veterans who are living with MS. We're sharing the details of a large study that determined routine vaccinations don't cause MS relapses. And if you're in New York and you're ready to laugh for a good cause, we have the details about the StandUp2MS comedy club benefit at Gotham Comedy Club. It's less than a week away! We have a lot to talk about! Are you ready for RealTalk MS??! This Week: Generic and biosimilar drugs for MS   :22 A simple blood test that can assess MS disease activity 1:51 Izzy Abbas explains how the Paralyzed Veterans of America supports veterans living with MS   7:19 The StandUp2MS comedy club benefit is less than a week away!  17:28 Study results show that routine vaccinations don't cause MS relapses   18:37 Dr. Jiwon Oh explains the differences and similarities between generics, biosimilars, and the name-brand drugs that they mimic   21:19 Share this episode  37:40 Have you downloaded the free RealTalk MS app?  38:00 SHARE THIS EPISODE OF REALTALK MS Just copy this link & paste it into your text or email: https://realtalkms.com/315 ADD YOUR VOICE TO THE CONVERSATION I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts! Email: jon@realtalkms.com Phone: (310) 526-2283 And don't forget to join us in the RealTalk MS Facebook group! LINKS If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com STUDY: Clinical Validation of a Multi-Protein, Serum-Based Assay for Disease Activity Assessments in Multiple Sclerosis https://www.sciencedirect.com/science/article/pii/S1521661623004515 Paralyzed Veterans of America https://pva.org Standup2MS Comedy Club Benefit https://standup2ms.org/comedy-club-benefit STUDY: Vaccines and the Risk of Hospitalization for Multiple Sclerosis Flare-Ups https://jamanetwork.com/journals/jamaneurology/article-abstract/2809144 National MS Society: Detailed information on vaccinations for people living with MS https://www.nationalmssociety.org/Living-Well-With-MS/Diet-Exercise-Healthy-Behaviors/Vaccinations#section-1 Join the RealTalk MS Facebook Group https://facebook.com/groups/realtalkms Download the RealTalk MS App for iOS Devices https://itunes.apple.com/us/app/realtalk-ms/id1436917200 Download the RealTalk MS App for Android Deviceshttps://play.google.com/store/apps/details?id=tv.wizzard.android.realtalk Give RealTalk MS a rating and review http://www.realtalkms.com/review Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com. RealTalk MS Episode 315 Guest: Izzy Abbas, Dr. Jiwon Oh Privacy Policy

Drs. Katherine Talcott and Joshua Uhr preview the September 2023 issue of Retinal Physician, found online at http://www.retinalphysician.com. Topics covered include high-dose aflibercept FDA approval, management of treatment-resistant wet AMD patients, biosimilar intravitreal injections, and lifestyle factors and AMDRelevant Financial Disclosures: Dr. Sridhar is a consultant for Genentech and Regeneron. Dr. Talcott is a consultant for Genentech.You can claim CME credits for prior episodes via the AAO website. Visit https://www.aao.org/browse-multimedia?filter=Audi

What's Your Mission? What's Your Purpose? On 'This Week in Pharmacy" Jennifer Bourgeois, Pharm.D is on the pods. She's a pharmacist, a mother, and an amazing Provider in McKinney, Texas. Dr. Bourgeois serves as a SingleCare spokesperson after being named Best Pharmacist in 2021. Next, catching up on biosimilars with Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim.  A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. We're talking about Cyltezo! 

Drs. Safa Rahmani, Akshay Thomas, and Priya Vakharia join to discuss four recent publications in major ophthalmology journals.Fluorescein Angiography Cost (https://ophthalmologyretina.org/article/S2468-6530(23)00227-0/fulltext)Intravitreal Biosimilar Cost Impact (https://www.aaojournal.org/article/S0161-6420(23)00295-6/fulltext)Practice Consolidation in Ophthalmology (https://www.aaojournal.org/article/S0161-6420(23)00311-1/fulltext)Physician Turnover in Ophthalmology (https://www.aaojournal.org/article/S0161-6420(23)00308-1/fulltext)Relevant Financial Disclosures: Dr. Rahmani is an investigator for Regeneron. Dr. Thomas is a consultant for Allergan and Novartis. Dr. Vakharia is a consultant for Genentech and Regeneron. Dr. Sridhar is a consultant for Genentech and Regeneron.You can claim CME credits for prior episodes via the AAO website. Visit https://www.aao.org/browse-multimedia?filter=Audi