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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.
13 Strategies to Avoid the Nocebo Effect During Biosimilar Switching
December 18th 2024A systematic review identified 13 strategies, including patient and provider education, empathetic communication, and shared decision-making, to mitigate the nocebo effect in biosimilar switching, emphasizing the need for a multifaceted approach to improve patient perceptions and therapeutic outcomes.
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.
Health Canada Approves First Omalizumab Biosimilar
December 16th 2024Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product.
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
Commercial Payer Coverage of Biosimilars: Market Share, Pricing, and Policy Shifts
December 4th 2024Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the increasing market share of biosimilars, which contributed to notable reductions in both average sales prices and wholesale acquisition costs.
