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The Top 5 Biosimilars Articles for the Week of July 30
The Center for Biosimilars® recaps the top 5 articles for the week of July 30, 2018.
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 July 30.
Number 5: The Maine legislature has authorized a bill that seeks to combat the misuse of Risk Evaluation and Mitigation Strategy programs within the state.
Number 4: Mylan, together with partner Fujifilm Kyowa Kirin Biologics, has gained a positive opinion on its adalimumab biosimilar from the European Medicines Agency’s Committee for Medicinal Products for Human Use. Mylan plans to sell the drug under the brand name Hulio.
Number 3: England’s National Health Service reports strong savings from biosimilars so far, and says that, this financial year, it could save as much as 100 million pounds, equivalent to 131 million dollars, by using biosimilars.
Number 2: The European Commission has approved Pfizer’s trastuzumab biosimilar, Trazimera, referencing Herceptin, for marketing.
Number 1: Mylan, which in June received FDA approval for its biosimilar pegfilgrastim, Fulphila, has launched the drug in the US marketplace.
Finally, last week, our e-newsletter asked whether eventual marketing of the second filgrastim biosimilar will improve patient access.
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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Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
BioRationality: No More Biosimilars—Just Biogenerics
February 3rd 2025Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy.
FTC Releases Second Report on PBMs Meddling in Generic Drug Markets
January 19th 2025The 3 largest pharmacy benefit managers (PBMs) increased many specialty generic drugs prices by hundreds of percent, with some drugs seeing thousands of percent markups, according to the Federal Trade Commission (FTC)’s second interim report on PBM practices.
Improving Biosimilar Access Through Global Regulatory Convergence
January 15th 2025Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.
