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The Top 5 Biosimilars Articles for the Week of September 2
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.
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How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
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April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
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.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
Latest Biosimilar Deals Signal Growth Across Immunology, Oncology Markets
April 14th 2025During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.
