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The Top 5 Biosimilar Articles for the Week of February 6
Here are the top 5 biosimilar articles for the week of February 6, 2023.
Hi, I’m Justina Petrullo 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 January 30th, 2023.
Number 5: Sandoz announced that the FDA has accepted the company’s biologics license application (BLA) for its denosumab biosimilar candidate for review.
Number 4: Sarfaraz K. Niazi, PhD, explained the FDA's changes to the drug review process, the significance of each change, and the published pieces of work that helped inform the FDA's decisions.
Number 3: The FDA published its research roadmap as part of the Biosimilars User Fee Act III regulatory research pilot program. The roadmap will allow stakeholders to see how the program will help the FDA enhance regulatory decision-making surrounding biosimilar development.
Number 2: This year started off with a bang for rheumatology biosimilars, with several regulatory approvals around the world, new market insight into the global use of biosimilars, and US market introduction of the first rival biosimilar to Humira (adalimumab).
Number 1: Amgen’s Amjevita (adalimumab-atto) has officially entered the US market, making it the first of potentially 10 biosimilars referencing Humira to launch in 2023.
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.
