Here are the top 5 biosimilar articles for the week of January 25, 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 January 25, 2021.
Number 5: Charles Bennett, MD, PhD, a hematologist, oncologist, and professor at the University of South Carolina, explained the many sticking points that prevent biosimilar savings.
Number 4: It took Henlius years to get a rituximab biosimilar approved in China. Now, that process could be cut in half, owing to significant regulatory reforms.
Number 3: An attempt by investigators to understand whether regulatory and scientific sources are consistent with each other in their reporting of quality attributes for biosimilars has demonstrated general conformance between these 2 sources of biosimilar information.
Number 2: The CEO of Prestige Biopharma said that biosimilars will be the cornerstone for a leap into biologics development and commercialization. Meanwhile, Innovent Biologics reaches a marketing agreement.
Number 1: Coherus BioSciences CEO Dennis M. Lanfear discusses the company's biosimilar marketing prospects in 2021.
To read all of these articles and more, visit centerforbiosimilars.com.
Challenges, Obstacles, and Future Directions for Anti-TNF Biosimilars in IBD
November 9th 2024A review article on tumor necrosis factor (TNF)-α inhibitors in inflammatory bowel disease (IBD) outlined current use of anti-TNF originators and biosimilars, their efficacy and safety, the benefits and challenges of biosimilars, and the future of biosimilars in IBD.
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.
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: Should mRNA Copies Be Filed as NDAs or Biosimilars?
November 4th 2024The article by Sarfaraz K. Niazi, PhD, argues that the FDA’s classification of future copies of messenger RNA (mRNA) products could be reconsidered, suggesting they might be eligible for new drug applications (NDAs) or a hybrid biosimilar category due to their unique characteristics and increasing prevalence.