Here are the top 5 biosimilar articles for the week of May 10, 2021.
Hi, I’m Skylar Jeremias 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 biosimilar articles for the week of May 10, 2021.
Number 5: During a talk at the Medicines for Europe Biosimilar Medicines Conference, US and EU regulators discuss the potential for a tailored approach to bring biosimilars to market sooner with less expense and wasted effort.
Number 4: Pfizer doubles down on its pledge to fight rebates, and Organon executives discuss the growth potential of the planned Merck spinoff.
Number 3: Fighting back against a suit that alleges theft of trade secrets, Alvotech has filed suit against AbbVie alleging that key patents for its blockbuster adalimumab drug (Humira) should be invalidated partly on grounds that AbbVie did not invent the processes that were patented.
Number 2: This year marks the 15th anniversary of biosimilar availability in the European Union, and in an overview sponsored by Medicines for Europe, experts from regulatory and business venues discussed some of the major achievements and hurdles yet to be crossed.
Number 1: A deep dive into the anatomy of a biosimilar switching study reveals what it takes for a biosimilar to be approved as interchangeable in the United States.
To read all of these articles and more, visit centerforbiosimilars.com.
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.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars
February 5th 2025Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
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.