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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.
AMCP Posters Tackle Interchangeability and Medicaid, Factors Driving Biosimilar Access
April 24th 2024Two posters from the Academy of Managed Care Pharmacy (AMCP) annual meeting explore how an interchangeable insulin glargine biosimilar plays into Medicaid budgets and the top factors driving access to biosimilars.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
The 6 Key Policy Factors to Ensure Biosimilar Market Sustainability
April 16th 2024Magnus Bodin, senior director and head of international access and policy at Biogen, presented warning signs for unsustainable biosimilar markets as well as key factors needed to create effective policies and future-proof biosimilar markets globally.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
