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The Top 5 Biosimilars Articles for the Week of October 30
The Center for Biosimilars® recaps the top 5 stories in biosimilars news for the week of October 30.
Transcript:
Hi, I’m Laura Joszt for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.
Here are the top 5 biosimilars articles for the week of October 30.
Number 5: The FDA has announced that it will recognize 8 European regulatory agencies as capable of conducting manufacturing facilities inspections that will meet FDA requirements.
Number 4: More than 90% of Americans believe that the cost burden of cancer is too high, according to a nationally representative survey conducted on behalf of the American Society of Clinical Oncology.
Number 3: A New York union has filed an antitrust lawsuit against Johnson & Johnson, alleging that the maker of the reference infliximab has engaged in anti-competitive practices to keep biosimilar competition at bay.
Number 2: Biosimilar developers Momenta and Mylan announced this week that M834, a proposed biosimilar of Orencia, did not meet its primary pharmacokinetic endpoints in a phase 1 study.
Number 1: 54-week results of a phase 3 study in patients with Crohn’s disease support the long-term effectiveness of treatment with the infliximab biosimilar CT-P13.
Finally, this week, The Center for Biosimilars® launched a new Peer ExchangeTM, titled "Regulation, Policy, and Litigation in Biosimilars." Follow the series to hear insights on the state of biosimilars from the clinical, legal, and product developer perspectives.
To read all of these articles and more, visit centerforbiosimilars.com.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.
