Podcasts about Biosimilar

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.

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.

it der Coronapandemie oder jüngst den Abnehm- bzw. Diabetesmedikamenten rückten in den vergangenen Jahren immer wieder Pharma- und Biotechunternehmen in den Fokus der Öffentlichkeit. Eine Nischensparte, die aktuell noch recht unbekannt ist, sind die sogenannten Biosimilars (Nachahmermedikamente). Doch was verbirgt sich konkret dahinter und wie sind die Wachstumsaussichten des Marktes? Diese und weitere Fragen bespricht der ES im Interview mit Finanzvorstand Enno Spillner.

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.

In the rapidly evolving landscape of biosimilars, intellectual property (IP) strategy is paramount. Biosimilar manufacturers face unique challenges, including navigating […] Source

In the high-stakes world of biosimilar development, manufacturers are increasingly turning to an unexpected partner: the Patent Trial and Appeal […] Source

In this episode, the fourth of our Biosimilars series, Christie Smith discusses the biosimilar payer perspective.If you have any questions for our guests or have a topic you would like to learn more about, email us at OnCallGPO@gmail.com.

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

Summary: Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast   Here are the highlights: Pembrolizumab (Keytruda) has received FDA approval for the treatment of metastatic biliary tract cancer, both in combination with chemotherapy and as a monotherapy. The approval is based on the positive outcomes of the KEYNOTE-966 trial, where patients receiving pembrolizumab plus chemotherapy demonstrated a statistically significant improvement in overall survival compared to those receiving a placebo with chemotherapy. Common adverse reactions included hematologic abnormalities, pyrexia, fatigue, cholangitis, and hepatic enzyme elevations. Approval was granted to Merck. Secukinumab (Cosentyx) has gained FDA approval for the treatment of moderate-to-severe hidradenitis suppurativa (HS), making it the first FDA-approved IL-17A inhibitor for this condition. Approval is based on results from the SUNSHINE and SUNRISE trials, showing significant improvements in response rates in HS patients treated with secukinumab compared to placebo. Ustekinumab-auub (Wezlana) has been granted FDA approval as an interchangeable biosimilar for Stelara, offering treatment options for multiple inflammatory diseases. It is indicated for moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in adult patients, as well as pediatric patients with plaque psoriasis and psoriatic arthritis. Vonoprazan (Voquezna) has received FDA approval for the treatment of erosive esophagitis (GERD). As a potent potassium-competitive acid blocker (PCAB), it offers an alternative to proton pump inhibitors (PPIs). Approval is based on the PHALCON-EE study, where vonoprazan demonstrated noninferiority to lansoprazole in healing GERD. Abatacept (Orencia) has been expanded for use in pediatric patients aged 2 years and older to treat psoriatic arthritis. Originally approved for rheumatoid arthritis in adults in 2005, abatacept was also approved for adult psoriatic arthritis in 2017. Exa-cel, a CRISPR-based therapy developed by CRISPR Therapeutics and Vertex, is under FDA review for sickle cell disease. The advisory panel has found it safe for clinical use, with potential approval expected in December. Exa-cel aims to alleviate sickle cell symptoms through gene editing technology Intro and outro music Garden Of Love by Pk jazz Collective  

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

FDA urge immediate discontinuation for eye drop products; safety alert issued for the pediatric Moderna COVID-19 vaccine; novel heartburn medicine approved; Stelara biosimilar approved; and an antibody to prevent fentanyl overdose gets fast tracked.

On this month's episode, Pharmacy Times covers the Academy of Managed Care Pharmacy Nexus 2023 conference, highlighting the updates on biosimilars. Interviews include: Chelsee Jensen, PharmD, BCPS a senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, Prerakkumar Parikh, PharmD, director of Specialty Clinical Solutions at Magellan Rx Management, and Kimberly Maxfield, PhD, from the FDA. For more Nexus 2023 coverage, visit pharmacytimes.com. Key Takeaways: Jensen discusses biosimilar approval updates, trends biosimilars, and what health care professionals can expect in the future. Parikh discusses the impact of interchangeable biosimilars, their cost-saving benefits, and the influx of biosimilars into pharmacy. Maxfield discusses the role pharmacists can take to reassure patients when switching to a biosimilar and the future of biosimilar development.

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.  

Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights:  Novavax COVID Vaccine:The updated Novavax COVID-19 vaccine is approved for use in the US for those 12 and older and is a conventional vaccine containing purified, full-length recombinant Spike (rS) protein. This rS protein stimulates the immune system to generate a protective immune response, specifically by eliciting antibodies against the Spike protein of the SARS-CoV-2 virus.  Rivfloza (Nedosiran) for Primary Hyperoxaluria:The FDA approved Rivfloza, an RNA interference therapy, to treat primary hyperoxaluria type 1 (PH1) patients by lowering urinary oxalate levels. The medication will be available for eligible patients in 2024. Intravenous Cosentyx:The FDA approved an intravenous (IV) version of Cosentyx for treating adults with certain rheumatic diseases, making it the only approved IV treatment that targets interleukin-17A (IL-17A). It will be available in Q4 of 2023. Abrilada Adalimumab Biosimilar:Abrilada has been designated as interchangeable with adalimumab, meaning it can be substituted at the pharmacy level without notifying the prescribing provider. It was proven to provide similar outcomes to the reference product even when patients switched between them multiple times. Injector for Empaveli in PNH:The FDA approved the enFuse® Injector for delivering Empaveli to adults with paroxysmal nocturnal hemoglobinuria (PNH). This device is the first purely mechanical, large-volume subcutaneous drug delivery device, and Enable Injections is collaborating with other manufacturers for its application. Intro and outro music Garden Of Love by Pk jazz Collective

Check out our free downloads at nascentmc.com: Implementing AMA Style – 8 Things to Get Right in Your Next Project Needs Assessments – 7 Essentials for Getting Funded Working With Your Medical Writer – 8 Ways to Get the Most out of Them See the full write ups for today's episode at nascentmc.com/podcast Here are the highlights: Ryzumvi (Phentolamine Ophthalmic Solution) for Dilated Pupil Reversal The FDA has approved Ryzumvi for treating pharmacologically-induced mydriasis (dilated pupils). Ryzumvi, formerly known as Nyxol, will be available in the US in 2024 and is currently the only commercially available treatment for reversing dilated eyes. Exxua (Gepirone Hydrochloride) for MDD Exxua, an antidepressant, has received FDA approval for the treatment of major depressive disorder in adults. Exxua has faced regulatory challenges in the past. It works through selective agonism of 5HT1a receptors without causing common antidepressant side effects like sexual issues or weight gain. Likmez, Liquid Formulation of Metronidazole The FDA has approved Likmez, the only liquid oral suspension of metronidazole in the US. The liquid formulation provides an alternative for patients who struggle with the tablet version due to taste or swallowing difficulties. DNA Test for Hereditary Cancers The FDA granted marketing authorization for Invitae Common Hereditary Cancers Panel, a diagnostic test identifying genetic risks for certain cancers. This is the first FDA-approved test of its kind, with over 99.0% accuracy in detecting variants in 47 cancer-associated genes. Tofidence (Actemra [toclizumab] Biosimilar) Tofidence, a biosimilar referencing Actemra, has been approved by the FDA for certain rheumatologic indications. A biosimilar, it closely resembles the FDA-approved biologic Actemra in safety, purity, and efficacy. Pombiliti + Opfolda for Pompe Disease The FDA approved Pombiliti + Opfolda, a two-component therapy for adults with Pompe disease. The therapy shows significant improvements in patient mobility and is designed to address enzyme deficiency while maintaining it's efficacy in Pompe disease. Subcutaneous Entyvio (Vedolizumab) for Moderate-to-Severe Ulcerative Colitis The FDA has approved a subcutaneous form of Entyvio for maintenance therapy in adults with ulcerative colitis. Previously approved as an intravenous formulation, this subcutaneous version achieved significant clinical remission in trials for use as maintenance therapy. Experimental Stromal Cell Platform in Mild-To-Moderate ALS The FDA Advisory committee voted against the effectiveness of BrainStorm Cell Therapeutics' NurOwn stromal cell therapy for mild to moderate ALS. BrainStorm Cell Therapeutics plans to initiate a phase 4 study in 2024. Intro and outro music Garden Of Love by Pk jazz Collective    

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Today's episode covers a range of updates in the industry.First, we turn our attention to the commercial hurdles facing RSV vaccines. Public health officials and drugmakers are working to raise awareness of RSV among older adults at risk. They are also encouraging them to get an additional respiratory shot alongside those for COVID-19 and flu. This rollout poses a test for the industry.In a recent House hearing, the pharmacy benefit manager lobby PCMA and drugmaker lobby PhRMA traded blame over problems in the prescription supply chain. They discussed the high costs of drugs and the role that PBMs play in driving up prices. This ongoing debate highlights the challenges within the industry.Moving on, Alvotech has received a new FDA review for its biosimilar of Humira. The regulator had previously rejected Alvotech's copycat drug due to manufacturing issues with a plant in Europe. This new review brings hope for Alvotech's biosimilar.Novartis has canceled its partnership with Beigene as its cancer drug gains EU approval. This decision leaves Novartis without a PD-1 inhibitor, marking a significant development for the company.Orchard is nearing an FDA decision on its rare disease gene therapy, Libmeldy. Three years after gaining European approval, Libmeldy is now under review in the US. This therapy has the potential to make a difference in the lives of patients.Shifting gears, an FDA panel has backed Alnylam's drug Onpattro for cardiomyopathy of ATTR amyloidosis, despite doubts over its benefit. This endorsement provides support for this drug's use in treating this condition.We also have various resources for further reading and upcoming events available. Check out Biopharma Dive and its publications for more information.In another news story, Roche's Genentech has partnered with PeptiDream to develop targeted radioisotopes for certain cancers. This collaboration expands their efforts in radiopharmaceuticals and shows promise for future treatments.Taysha has made the decision to drop its lead gene therapy, TSHA-120, following feedback from the FDA. The agency proposed additional studies that Taysha determined would be too challenging to pursue. Additionally, Taysha's partner, Astellas, has declined to pick up an option for the therapy. These developments mark a setback for Taysha.The FDA has also rejected ARS Pharmaceuticals' Neffy as a nasal spray for allergic reactions. Despite receiving backing from the Pulmonary-Allergy Drugs Advisory Committee, this rejection is a setback for ARS. The nasal spray was seen as an alternative to the EpiPen for severe allergic reactions.In other news, Genentech and PeptiDream have signed a potential $1 billion deal for the development of macrocyclic peptide-radioisotope drug conjugates. This partnership has the potential to advance cancer treatments and improve patient outcomes.Recode Therapeutics has raised $260 million in a series B financing round to advance its mRNA therapies. This funding will support further development in this promising field.The clearance of the Amgen-Horizon merger has been seen as a setback to the FTC's antitrust enforcement plans. The consent agreement between Amgen, Horizon Therapeutics, and the FTC could have significant implications for future merger and acquisition challenges.Lastly, Verisim Life has released an ebook on how artificial intelligence can transform R&D with early-stage translational insights in model-informed drug development. This resource provides valuable information on the potential of AI in drug development.That's all for today's episode. Thank you for tuning in to Pharma and Biotech Daily. Stay informed and stay ahead in the industry.

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

Summary: In this week's New FDA Approval's podcast episode, Dr. Emma Hitt Nichols discusses the latest FDA approvals from August 21, 2023 – August  25, 2023.  Please check back every Monday morning so that you can stay up to date. See more details summaries and links to prescribing information at nascentmc.com/podcast Here are the highlights:  FDA Approves Tyruko as First Biosimilar to TysabriThe FDA approved Tyruko as the first biosimilar to Tysabri for treating relapsing forms of MS in adults. It has similar risks and side effects as Tysabri and is also approved for treating certain Crohn's Disease patients. The product is available from Sandoz Inc. Source Abrysvo RSV Maternal Immunization ApprovedThe FDA approved Abrysvo, a vaccine for preventing respiratory disease caused by RSV in infants through maternal immunization. The approval is based on Phase 3 MATISSE trial results. Abrysvo was also approved for older adults earlier this year. Source sBLA Filed for Rybrevant in Advanced NSCLCAn sBLA was filed for expanded approval of Rybrevant, combined with certain drugs, for treating advanced non–small cell lung cancer with EGFR exon 20 insertion mutations. The approval was granted to Janssen Pharmaceuticals. Source Priority Review of Xtandi in Early PCaXtandi received Priority Review by the FDA for an expanded use in early-stage prostate cancer. The sNDA is based on a Phase 3 EMBARK trial, where Xtandi showed significant benefits. The product is manufactured by Pfizer, Inc.  Intro and outro music Garden Of Love by Pk jazz Collective    

Show notes To read CFB's analysis of the paper, click here. To view the full version of the paper, click here. To learn more about the Biosimilars Forum and its members, click here. To read the IQVIA report cited in the paper, click here. To read the IQVIA report cited in the paper, click here.

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

Sue Peschin, President and CEO of the Alliance for Aging Research, says Medicare coverage for Alzheimer's drugs is something millions across the country truly care about as an election year nears; the Biden Administration is taking action to limit insurance “junk fees” for patients; Patients Rising Now will host a Hill briefing on Accelerated Approval on Monday, July 24th; and Sarah Ikenberry, Senior Communication Advisor for the Office of Therapeutic Biologics and Biosimilars at the FDA, discusses the biosimilar landscape as new Humira biosimilars hit the market. Alliance for Aging Research Poll: Huge Majorities Want Medicare to Cover Cost of Alzheimer's Drugs Register: The Value of Accelerated Approval for Patient Access & Future Medical Advances Event FDA Webpage: Biosimilars Real Clear Markets OpEd: Promising New Alzheimer's Drug Calls for CMS to Rethink Access Restrictions

We discuss the use of biosimilar drugs for retinal diseases with Dr. Arghavan Almony, author of definitive monograph of these agents.

In this episode, Greg and Rob discuss a recent publication regarding how 340B Program participation may impact the degree of biosimilar utilization.  Additionally, the guys recap recent legislative proposals with 340B impact that were advanced by the House Energy & Commerce Committee.   Article citation:  Health Affairs 42, NO. 5 (2023): 632–641 

To learn more about Tasmina's Asembia 2023 presentation, click here. Check out the full AmerisourceBergen Biosimilar pipeline report. To listen to Brian's past appearance on Not So Different, click here.