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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.
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February 4th 2025Biosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.
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January 21st 2025In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.
FTC Releases Second Report on PBMs Meddling in Generic Drug Markets
January 19th 2025The 3 largest pharmacy benefit managers (PBMs) increased many specialty generic drugs prices by hundreds of percent, with some drugs seeing thousands of percent markups, according to the Federal Trade Commission (FTC)’s second interim report on PBM practices.
