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The Top 5 Biosimilar Articles for the Week of March 7
Here are the top 5 biosimilar articles for the week of March 7, 2022.
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 March 7, 2022.
Number 5: AbbVie settled outstanding lawsuits, including International Trade Commission (ITC) case, with Alvotech, giving Alvotech the green light to launch its high-concentration, citrate-free adalimumab biosimilar referencing Humira in July 2023, pending FDA approval.
Number 4: The FDA has approved Releuko (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen developed by Amneal Pharmaceuticals and Kashiv Biosciences. The biosimilar marks the third filgrastim biosimilar to be approved for the US market.
Number 3: Shanghai Henlius Biotech announced a commercialization agreement with Getz Pharma Limited for an adalimumab biosimilar for various African and Asian countries.
Number 2: As part of a new partnership between the companies, Biocon Biologics announced that it will acquire Viatris’ entire biosimilar portfolio for up to $3.3 billion.
Number 1: The FDA has accepted biologics license applications (BLAs) for interchangeability status from Alvotech and Pfizer regarding their respective adalimumab biosimilars referencing Humira.
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.
