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The Top 5 Biosimilars Articles for the Week of May 6
The Center for Biosimilars® recaps the top news for the week of May 6, 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 May 6.
Number 5: Last week, Coherus BioSciences announced that it has reached a settlement with Amgen over a trade secret case. Separately, Amgen filed a new complaint against Samsung Bioepis.
Number 4: The pan-Canadian Pharmaceutical Alliance and Cancer Care Ontario have partnered to create a new biosimilars initiative.
Number 3: Now that its comment period has closed, the FDA has heard from a variety of stakeholders who asked the agency to reconsider its guidance on biosimilar naming.
Number 2: A new review of the available literature on switching sought to address provider concerns about biosimilars.
Number 1: The idea of giving the Federal Trade Commission more authority to cut through patent thickets blocking biosimilar competition was raised during a hearing of the Senate Judiciary Committee.
Finally, last week, our e-newsletter asked whether you agree with a recent proposal that suggests regulating biologics’ prices rather than continuing to develop the US biosimilars market.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.
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?
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
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.
