On this episode of Not So Different, we recap some of the biosimilar policy news from the around the world during October, including the implementation of a biosimilars switching policy, the European Union declaration of biosimilars as interchangeable, and the reauthorization of the Biosimilars User Fee Act.
On this episode of Not So Different, we recap some of the biosimilar policy news from the around the world during October, including the implementation of a biosimilars switching policy, the European Union declaration of biosimilars as interchangeable, and the reauthorization of the Biosimilars User Fee Act.
Show notes
Saskatchewan Becomes Sixth Canadian Province to Implement a Biosimilar Switching Policy
Advocacy Organization Calls for Ontario to Switch Patients to Biosimilars
BioRationality: a Dr Sarfaraz Niazi Column—The EMA Declares Biosimilars Interchangeable
Biden Authorizes Update to the Biosimilar User Fee Act Through 2027
New Bill Aims to Remove Barriers to Interchangeable Biosimilars
Amgen Report: Biosimilars Have Saved $21 Billion in 6 Years
It’ll Take a Village: Collaborative Efforts Needed to Increase Ophthalmology Biosimilar Uptake
Order of Operations: Managing Biosimilars While Maintaining Operational Efficiency
Dr Ryan Haumschild: What Health Systems Can Learn From Emory Healthcare's Biosimilar Strategy
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February 9th 2025In this episode of Not So Different, host Skylar Jeremias covers the latest biosimilar developments, including new FDA approvals, patent disputes, and biosimilar market trends shaping the health care landscape.
CHMP Pushes 3 Biosimilars Forward, Spelling Hope for Ophthalmology, Supportive Care Markets
February 6th 2025The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.
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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.
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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.