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The Top 5 Biosimilar Articles for the Week of March 22
Here are the top 5 biosimilar articles for the week of March 22, 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 March 22, 2021.
Number 5: Peter Bach, MD, MAPP, and his Drug Pricing Lab at Memorial Sloan Kettering (MSK) argue profit caps will do better than the current biosimilar system.
Number 4: Animal toxicology studies contribute little to demonstrations of biosimilarity and yet these studies frequently must be done to satisfy international regulatory requirements, investigators conclude.
Number 3: Biosimilars are intended to save money for the health care system, but for many reasons, they are not succeeding in this mission, Harvard authors argue.
Number 2: AbbVie, the maker of originator adalimumab, has filed a suit against biosimilar developer Alvotech for unlawful receipt of trade secrets related to the production of its very successful high-concentration adalimumab formulation.
Number 1: Merck said it is taking steps to register its planned biosimilar and women’s health products spinoff as a publicly traded stock corporation.
To read all of these articles and more, visit centerforbiosimilars.com.
Duke Publishes Recommendations for Developing CGT Biosimilars
October 9th 2024Transformative cell and gene therapies (CGT) offer promising treatments for serious conditions, but high costs and complex biologics limit competition, requiring policies that support the development of biosimilars to enhance affordability and patient access.
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—The Evolution of the BPCIA and the Bright Future of Biosimilars in the US
October 7th 2024The Biologics Price Competition and Innovation Act (BPCIA) of 2010 initially posed significant barriers to biosimilar development, but regulatory reforms over the years have drastically reduced costs and approval times, with further advancements expected by 2025 that will foster competition and drive down prices.
