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.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Unifying Standards: The Need for Streamlined Biosimilar Development
October 22nd 2024At the 2024 GRx+Biosims conference, industry leaders and regulatory experts underscored the urgency of unifying global standards and simplifying the biosimilar development process, sharing insights on recent advancements and the necessity for greater collaboration between manufacturers and regulatory agencies.
Phase 3 Study Reports Similar Efficacy Between SB17, Stelara in Psoriasis
October 19th 2024A phase 3, 28-week comparative clinical trial in patients with moderate to severe plaque psoriasis confirmed similarity of the proposed ustekinumab biosimilar SB17 (Samsung Bioepis) to the reference product (Stelara) in efficacy, safety, pharmacokinetics, and immunogenicity.