Here are the top 5 biosimilar articles for the week of February 28, 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 February 28, 2022.
Number 5: A report from the National Alliance of Healthcare Purchaser Coalitions detailed the common concerns employers have regarding implementing biosimilars within their health care plans and outlined how they could take charge and make a difference.
Number 4: Switching patients with Crohn disease from reference adalimumab to SB5, a Samsung Bioepis biosimilar, did not lead to major changes in disease activity in a real-world analysis.
Number 3: There remains risk in the US market due to regulatory and legal hurdles—not to mention a combative political environment, said executives during the “CEOs Unplugged” session at Access! 2022, held by the Association for Accessible Medicines (AAM) in Orlando.
Number 2: Prestige BioPharma has announced that the manufacturing facility for Tuznue, a proposed trastuzumab biosimilar, has received European Union (EU) Good Manufacturing Practices (GMP) certification.
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.