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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.
Boosting Health Care Sustainability: The Role of Biosimilars in Latin America
November 21st 2024Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
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.
Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data
November 19th 2024The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
Breaking Down Biosimilar Barriers: Interchangeability
November 14th 2024Part 3 of this series for Global Biosimilars Week, penned by Dracey Poore, director of biosimilars at Cardinal Health, explores the critical topic of interchangeability, examining its role in shaping biosimilar adoption and the broader implications for accessibility.
