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The Top 5 Biosimilars Articles for the Week of March 9
The Center for Biosimilars® recaps the top stories for the week of March 9, 2020.
Hi, I’m Christina Mattina 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 March 9, 2020.
Number 5: The FDA released a question-and-answer guidance for the industry about the transition coming March 23 for how certain products will be approved under a biological pathway, including exceptions to the transition and how companies will receive notifications about their applications.
Number 4: The US biosimilars market is showing healthy vital signs, said Leah Christl, Amgen’s executive director for Global Regulatory and R&D policy, while reassuring an audience that her former FDA colleagues are still champions of their work.
Number 3: The combination of growing biosimilar awareness, patent expirations, and demands to lower healthcare costs will increase uptake over the next few years, setting up some pharmaceutical firms to advance while putting others at risk, according to a recent S&P Global Ratings report.
Number 2: The FDA has granted the application for Mylan’s bevacizumab biosimilar a decision date of December 27, 2020.
Number 1: Katie Verb, director of policy and research for the biopharmaceutical industry group PhRMA, discussed recent policy changes that have increased biosimilar uptake and additional measures that could lead to greater use of biosimilars and savings for CMS and patients.
To read all of these articles and more, visit centerforbiosimilars.com.
Samsung Bioepis Report Signals Turning Point for US Biosimilars
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How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
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Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
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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.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
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.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
