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The Top 5 Biosimilars Articles for the Week of November 20
The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of November 20.
Transcript:
Hi, I’m Kelly Davio 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 November 20.
Number 5: The European Medicines Agency will move to Amsterdam, Netherlands, after European ministers voted on the agency’s post-Brexit relocation.
Number 4: A recently published case study shows that a non-medical switch to biosimilar infliximab was associated with a rapid loss of treatment response in multiple patients with Behçet's disease.
Number 3: Samsung Bioepis has been granted the first European marketing authorization for a trastuzumab biosimilar, referenced on Herceptin.
Number 2: Stacie Phan, president of the Biosimilars Forum, explains the critical need for US physicians to gain better education on biosimilar therapies.
Number 1: Swiss drug maker Roche has sued biosimilar developer Pfizer over its proposed trastuzumab biosimilar.
Finally, last week, our e-newsletter asked whether you think that the so-called “nocebo” effect adequately explains patients switching away from biosimilars. To view results of the poll, visit The Center for Biosimilars® on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
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.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
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.
