The Center for Biosimilars® recaps the top stories for the week of September 2, 2019.
Transcript
Hi, I’m Jaime Rosenberg 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 September 2, 2019.
Number 5: At Amgen’s request, the Patent Trial and Appeal Board will review several key patents on Alexion’s Soliris.
Number 4: Canada’s regulatory body recently updated its fact sheet on biosimilars, including new or clarified information about key topics such as switching.
Number 3: England’s National Health Service says that it has saved the equivalent of $134 million on adalimumab after Humira lost patent protection in 2018.
Number 2: The FDA has given Mylan and Biocon a second Complete Response Letter for their follow-on insulin glargine.
Number 1: Biosimilars for multiple sclerosis drugs are now on the horizon after Sandoz announced its plan to commercialize a biosimilar natalizumab.
Finally, last week, our e-newsletter asked whether you agree with a new treatment guideline that recommends that stable patients not be required to switch to biosimilars.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements
February 25th 2025The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.