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The Top 5 Biosimilars Articles for the Week of March 25
The Center for Biosimilars® recaps the top news for the week of March 25, 2019.
Transcript:
Hi, I’m Samantha DiGrande 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 25.
Number 5: The FDA's updated guidance on the naming of biologics has caused concern among some proponents of biosimilars, and one stakeholder has now filed a citizen petition with the FDA in which he asks that the guidance be withdrawn.
Number 4: Roche has reached a confidential US patent settlement with Pfizer regarding its brand-name rituximab, Rituxan.
Number 3: Spectrum Pharmaceuticals has withdrawn its Biologics License Application for a novel granulocyte colony-stimulating factor therapy that the company had hoped to sell under the brand name Rolontis.
Number 2: The Department of Justice has issued a letter saying that the Affordable Care Act should indeed be struck down, raising questions about the future of the biosimilar approval pathway.
Number 1: A research letter published this week shows that biosimilars of insulin can generate significant cost savings.
Finally, last week, our e-newsletter asked which policy proposal recently put forward by the Trump administration would most encourage biosimilars.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
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.
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?
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.
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.
