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The Top 5 Biosimilars Articles for the Week of March 5
The Center for Biosimilars recaps the top 5 biosimilars articles for the week of March 5, 2018.
Transcript:
Hi, I’m Laura Joszt 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 5.
Number 5: Michigan has become the latest state to enact legislation governing the pharmacy-level substitution of interchangeable biosimilars.
Number 4: Dr Gillian Woollett, of Avalere Health, told The Center for Biosimilars® that the United States does not have to reinvent the wheel on biosimilar safety, but can learn from international experience.
Number 3: A systematic literature review shows that switching to a biosimilar carries only a low risk of safety concerns or loss of efficacy.
Number 2: Samsung Bioepis’ Ontruzant launched in the United Kingdom this week as the first biosimilar trastuzumab to enter the European market.
Number 1: Dr Scott Gottlieb, Commissioner of the FDA, said in remarks delivered at the National Health Policy Conference of America’s Health Insurance Plans that the economics of biosimilar development in the United States are "currently unstable."
Finally, last week, our e-newsletter asked for your thoughts on whether the FDA should levy fines against research entities that fail to disclose their clinical trial data.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.
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?
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.
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.
