Podcasts about biologics price competition

Join Drs Stanley Cohen and Jonathan Kay as they discuss biosimilars in PsA, which will hit the US market this summer. They cover everything from working with your pharmacy to counseling patients. Relevant disclosures can be found with the episode show notes on Medscape (https://www.medscape.com/viewarticle/984272). The topics and discussions are planned, produced, and reviewed independently of advertisers. This podcast is intended only for US healthcare professionals. Resources Psoriatic Arthritis https://emedicine.medscape.com/article/2196539-overview Biosimilars for the Treatment of Psoriatic Arthritis https://pubmed.ncbi.nlm.nih.gov/31625769/ Biosimilars and the Extrapolation of Indications for Inflammatory Conditions https://pubmed.ncbi.nlm.nih.gov/28255229/ Adalimumab (Rx) https://reference.medscape.com/drug/amjevita-humira-adalimumab-343187 Comparison of Skindex-29, Dermatology Life Quality Index, Psoriasis Disability Index and Medical Outcome Study Short Form 36 in Patients With Mild to Severe Psoriasis https://pubmed.ncbi.nlm.nih.gov/22229951/ Infliximab (Rx) https://reference.medscape.com/drug/remicade-inflectra-infliximab-343202 Rituximab (Rx) https://reference.medscape.com/drug/rituxan-truxima-rituximab-342243 Subcutaneous Injection of Drugs: Literature Review of Factors Influencing Pain Sensation at the Injection Site https://pubmed.ncbi.nlm.nih.gov/31587143/ Biosimilars to Bring a Bumper Crop of Adalimumab Options https://www.centerforbiosimilars.com/view/part-1-biosimilars-to-bring-a-bumper-crop-of-adalimumab-options The Difference Between an Interchangeable Biosimilar and One That Isn't https://www.centerforbiosimilars.com/view/the-difference-between-an-interchangeable-biosimilar-and-one-that-isn-t The Non-Medical Switching of Prescription Medications https://pubmed.ncbi.nlm.nih.gov/31081414/ Implementation of the Biologics Price Competition and Innovation Act of 2009 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/implementation-biologics-price-competition-and-innovation-act-2009 Systematic Review on the Use of Biosimilars of Trastuzumab in HER2+ Breast Cancer https://pubmed.ncbi.nlm.nih.gov/36009592/ Certolizumab pegol (Rx) https://reference.medscape.com/drug/cimzia-certolizumab-pegol-343185

In this episode, the third of our biosimilar education series, Neil Udovich spoke with Kathy Oubre, CEO of Pontchartrain Cancer Center, about the FDA approval process for biosimilars, the Biologics Price Competition and Innovation Act and safety issues or adverse effects related to biosimilar use. 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. 

0:00 Intro0:57 FDA Bans Compounded HCG, FSH & HMG2:31 Biologics Price Competition and Innovation Act of 2009 & Insulin Pricing5:02 Different Types of Insulin10:26 Real Cost of High Priced Medicines11:50 Open Source Insulin13:51 How Medicine Patents Work - BS14:29 Why is Aromasin so Expensive in the US?16:38 Why isn't Sustanon 250 FDA Approved?17:09 Hucog HCG from India18:00 ADHD Meds tainted with Fentanyl21:28 Your being ripped off! - Medicine Middle Men24:50 PPI's - Proton Pump Inhibitors - Heart Burn Alternatives26:30 Leaky Gut, CBOW, Gut Issues31:15 Lectins - Hidden Inflammation in the body38:34 Another Bad Episode for TYL :(40:10 Pressurized Tubes of $h!T46:00 Do Needles Actually Cause Scar Tissue?49:05 Our Injection Preferences51:30 How to Measure your Member Correctly52:22 Can You Grow Your Member?55:12 Fitness Influencer Exercises and Programs61:32 Watch the Biggest Guy in Your Gym Workout63:00 Super Set Sam64:14 How WE Workout67:39 David Calls Out TYL's Check Workouts - Flat Bench71:25 Our Goals73:00 David going Pro?78:30 David Coaching Sam for His First Show?78:53 Outro#MensHealthPodcast #TestosteronePodcast #BodybuildingPodcastTest Your Levels Linkshttps://linktr.ee/testyourlevelsYoutubeInstagramTikTokSam Stolt's Linkshttp://bit.ly/sam-stolt-linksYoutubeInstagramTikTokTwitterDavid DeMesquita Linkshttps://taplink.cc/dynamite_dYoutubeInstagram

In this episode, CancerNetwork spoke with 2 experts on the topic of biosimilars, Howard Hochster, MD, FACP, Associate Director for Clinical Research at the Rutgers Cancer Institute of New Jersey and Distinguished Professor of Medicine at the Rutgers School of Medicine, and Michael Kane, RPh, BCOP, Executive Director of Oncology Pharmacy Services for RWJBarnabas Health and Director of Pharmacy Services and the Research Pharmacy at the Rutgers Cancer Institute of New Jersey. The episode dives into the background of biosimilars, including the Biologics Price Competition and Innovation Act (BPCIA) passed by the United States Congress in 2009 and subsequent 4-letter suffix rule used to identify biologics products without confusion. The conversation also analyzed some of the unintended consequences of these actions regarding biosimilars, and what Hochster and Kane would do to improve the system that's currently in place.

In the past decade of experience with the the Biologics Price Competition and Innovation Act, a number of questions about the biosimilar pathway have been resolved through litigation. This week on the podcast, we're speaking with attorneys Robert Cerwinski, JD, and Alexandra Valenti, JD, both of whom are partners at Goodwin, about experience with litigation, the road ahead for biosimilars, and Goodwin's recently published guide to biosimilar litigation. 

Recently, the FDA released its long-anticipated final guidance on demonstrating interchangeability, and developers have been grappling with how the guidance will impact them. This week on the podcast, we're speaking with regulatory attorney James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP. In a prior role, Shehan had a hand in crafting the language that became the Biologics Price Competition and Innovation Act, which set forth the legal standard for interchangeability. Shehan discusses what the newly released guidance means for developers, what he thinks about the upcoming transition of insulins to regulation as biologics, and his view on the potential for interchangeable insulin biosimilars.

Dr. Scott Kjelson, PharmD, host of the PolitiTalkRx Podcast welcomes Edward Li, PharmD, working within Health Economics and Outcomes Research to better understand the value of drugs and biologics. Today Scott & Edward dive into the topic of Biosimilars.  A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Congress, through the Biologics Price Competition and Innovation Act (BPCI Act) of 2009, created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product. This pathway was established as a way to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition. FDA requires biosimilar and interchangeable biological products meet the Agency's rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference product. See omnystudio.com/listener for privacy information.

Dr. Scott Kjelson, PharmD, host of the PolitiTalkRx Podcast welcomes Edward Li, PharmD, working within Health Economics and Outcomes Research to better understand the value of drugs and biologics. Today Scott & Edward dive into the topic of Biosimilars.  A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Congress, through the Biologics Price Competition and Innovation Act (BPCI Act) of 2009, created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product. This pathway was established as a way to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition. FDA requires biosimilar and interchangeable biological products meet the Agency's rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference product. See omnystudio.com/listener for privacy information.

In 2010, the Biologics Price Competition and Innovation Act signed into law by President Barack Obama as part of the Affordable Care Act, aimed to promote the development of biological products and create competition, with the goals of increasing treatment options and reducing health care costs. On this episode, we are joined by Dr. Leah Christl who is the Associate Director for Therapeutic Biologics in the Office of New Drugs in the FDA's Center for Drug Evaluation and Research. Today, we are starting to see the fruits of that labor, there are several biosimilars on the market and more are under review for approval. In 2015, the U.S. Food and Drug Administration approved the first biosimilar product which happens to be a supportive treatment for cancer patients undergoing chemotherapy for acute myeloid leukemia.

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides an abbreviated pathway for obtaining Food and Drug Administration (FDA) approval of a drug that is biosimilar to an already licensed biological product. Among other things, BPCIA provisions require applicants for approval of a new biosimilar to provide the manufacturer of the already licensed product with a notice of commercial marketing and certain information about the biosimilar. Failure to comply permits the manufacturer to pursue infringement litigation against the applicant on an accelerated basis. -- Amgen claims to hold patents on methods of manufacturing and using filgrastim--a biologic used to stimulate the production of white blood cells--and markets one such product, Neupogen. Sandoz sought FDA approval to market a biosimilar called Zarxio. When the FDA accepted Sandoz’s application for review, Sandoz notified Amgen that Sandoz intended to market Zarxio upon receipt of FDA approval. Sandoz also indicated that it would not share with Amgen the relevant application and manufacturing information as required by the BPCIA and invited Amgen immediately to sue for infringement. Amgen did so, and further asserted claims for “unlawful” conduct in violation of California’s unfair competition law. The basis for the latter claims was Sandoz’s alleged failure to comply with the BPCIA requirements that Sandoz (a) share the application and manufacturing information pertaining to Zarxio, and (b) provide a notice of commercial marketing prior to obtaining FDA licensure. Amgen sought injunctive relief in federal district court to enforce both requirements against Sandoz, which counterclaimed for declaratory judgments that Amgen’s patent was invalid and not infringed, and that Sandoz had not violated the BPCIA. -- While the litigation was pending, the FDA licensed Zarxio, and Sandoz provided Amgen with further notice of commercial marketing. The district court thereafter granted partial judgment in favor of Sandoz on its BPCIA counterclaims and dismissed Amgen’s unfair competition claims with prejudice. A divided U.S. Court of Appeals for the Federal Circuit affirmed in part, vacated in part, and remanded the case. The Federal Circuit held that Sandoz had not violated the BPCIA disclosure requirements and that Amgen could not pursue state law remedies to enforce the BPCIA. The court also held that an applicant may provide effective notice of commercial market only after FDA licensure and therefore enjoined Sandoz from marketing Zarxio until 180 days passed after Sandoz’s second notice. -- By a vote of 9-0, the Supreme Court unanimously vacated in part and reversed in part the judgment of the Federal Circuit and remanded the case. In an opinion by Justice Thomas, the Court held that the BPCIA’s requirement on sharing application and marketing information is not enforceable by an injunction under federal law, but that the Federal Circuit should determine on remand whether a state-law injunction is available. The Supreme Court further held that an applicant may provide the requisite notice of commercial marketing before obtaining FDA licensure; therefore Sandoz fully complied with this requirement through its initial notice, the Federal Circuit erred in enjoining Sandoz from marketing Zarxio on this basis, and Amgen’s state law unfair competition claim predicated on the view that the BPCIA forbids pre-licensure notice must fail. Justice Breyer issued a concurring opinion. -- And now, to discuss the case, we have Erika Lietzan, who is Associate Professor of Law at the University of Missouri School of Law.

In a decision likely to shape not only future biosimilar litigation but the biosimilar industry generally, the U.S. Supreme Court on June 12, 2017 handed down its much-anticipated ruling in Amgen v. Sandoz. -- In the first case interpreting the Biologics Price Competition and Innovation Act (BPCIA), the Court (J. Thomas) unanimously reversed the Court of Appeals for the Federal Circuit, holding that biosimilar makers need not wait for FDA approval before providing the reference product sponsor with 180-day notice of commercial marketing. The Court also held that the statute does not provide a federal injunctive cause of action to force biosimilar applicants to provide their FDA application to the reference sponsor, but remanded to the Federal Circuit to determine whether injunctive relief might be available to reference sponsors under state law. The decision raises intriguing questions of statutory construction and policy and is expected to speed market entry of biosimilars and increase competition.The Federalist Society’s uniquely qualified, expert panel discussed the decision and its implications for the industry and patent rights generally. -- Featuring: Prof. Gregory Dolin, Co-Director, Center for Medicine and Law, University of Baltimore School of Law and Prof. Erika Lietzan, Associate Professor of Law, University of Missouri School of Law.

The Biologics Price Competition and Innovation Act of 2010 (42 U.S.C. § 262) created an abbreviated pathway for FDA approval of biological products determined to be “biosimilar” to a reference product. The Act outlines a patent resolution and information exchange scheme, with litigation safe harbors during this “patent dance.” -- Subsection (l)(2)(A) provides that not later than 20 days after the application is accepted for review, “…the subsection (k) applicant – shall provide to the reference product sponsor a copy of the application…and other information that describes the processes used to manufacture the biological product…” Subsection (l)(8)(A) provides “[t]he subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).” -- In 2015, Sandoz filed a subsection (k) application based on Amgen’s filgrastim (Neupogen®), but refused to provide its (l)(2)(A) disclosure and claimed that pre-FDA approval notice satisfied (l)(8)(A). Amgen sued in federal court on state law claims of unfair competition and conversion, and patent infringement, and requested a preliminary injunction. The district court granted Sandoz’ motion for partial summary judgment, holding that (l)(2)(A) disclosure was optional and that Sandoz did not have to wait for FDA approval before providing (l)(8)(A) notice. -- In a fractured opinion, the Federal Circuit affirmed on the (l)(2)(A) issue, holding that subsection (l)(9)(C) provided a remedy for the reference product sponsor to bring an immediate declaratory judgment action if the subsection (k) applicant failed to provide its (l)(2)(A) information, showing that disclosure was optional. The court reversed on the (l)(8)(A) issue, holding that notice before the FDA approved the subsection (k) application was ineffective under the statute. The Court granted certiorari on both issues. -- This case presents intriguing questions of statutory interpretation, as the boundaries of the BCPIA are explored. -- Featuring: Mr. Andrew A. Hufford, Intellectual Property Attorney, Brinks Gilson & Lione.

J. Morgan Kirley, Shareholder – August 1, 2015 – In a closely-watched case between Amgen and Sandoz regarding the first biosimilar approved (Zarxio), the Federal Circuit interpreted key Biologics Price Competition and Innovation Act (BPCIA) provisions regarding Sandoz’s obligation to disclose information related to its application, and whether Sandoz could effectively provide notice of commercial marketing before FDA approval. The Federal Circuit decided that certain information-sharing requirements of the BPCIA are optional, because Amgen, the reference product sponsor (RPS) in this case, can obtain such information through discovery following suit for patent infringement, and that is the sole remedy contemplated by the BPCIA.