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The Top 5 Biosimilars Articles for the Week of December 11
The Center for Biosimilars® recaps the top 5 articles for the week of December 11.
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 December 11.
Number 5: Industry trade and lobbying group PhRMA sued California state officials in federal court over the state’s new drug pricing law, which the group calls “unprecedented and unconstitutional.”
Number 4: In a new comment letter, the American College of Rheumatology praised the FDA for considering ways to reduce regulatory burden, but called on the FDA to focus on 6 minimum components of review and oversight for biosimilars.
Number 3: The federal circuit ruled in Amgen v Sandoz that state law cannot compel drug makers to comply with the so-called patent dance.
Number 2: The FDA has granted final approval to the first short-acting follow-on insulin product, Sanofi’s Admelog.
Number 1: The FDA has approved Pfizer’s second infliximab biosimilar, Ixifi.
Finally, last week, our e-newsletter asked whether you think the United States should follow the European Commission’s lead in requiring industry to produce consensus documents on biosimilars. To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
Duke Publishes Recommendations for Developing CGT Biosimilars
October 9th 2024Transformative cell and gene therapies (CGT) offer promising treatments for serious conditions, but high costs and complex biologics limit competition, requiring policies that support the development of biosimilars to enhance affordability and patient access.
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.
Treatment Persistence, Safety After Switching to Infliximab Biosimilars in Canadians With IBD
October 5th 2024A retrospective study of a mandatory nonmedical switch in Canada found no significant differences in rates of treatment persistence, loss of response, or adverse events in patients with inflammatory bowel disease (IBD) on maintenance therapy 1 year post-switch.
Biosimilar Policy Roundup—September 2024
October 1st 2024In September 2024, the FDA approved a new biosimilar for treating retinal conditions, marking a significant development in the biosimilars landscape, coinciding with ongoing legal disputes in the industry and highlighting broader trends in market dynamics and regulatory challenges.
