A recent article lays out some of the hurdles the biosimilars industry faces, from the perspectives of oncology providers.
By 2023, as many as 20 biologic originator drugs could lose their patent protection, stimulating the development of more biosimilars. But many clinicians in the United States are still on the fence about incorporating biosimilars into their practice. A recent OncLive® article discusses the emergence of biosimilars as a class of drugs from the viewpoints of clinicians on the front lines in oncology.
The medical science underlying biosimilars is solid, and it’s a matter of convincing physicians that these agents are as safe and effective as the reference products they’re based on, according to the article, which notes that large proportions of providers still have difficulty defining biosimilars successfully or understanding the differences between biosimilars and generics. Patients also may not know enough about biosimilars to accept them if recommended by providers.
The provider-patient hurdle is not the only one. Biosimilar developers must overcome patent obstructions that may delay the market entry of these drugs by many years. In the case of etanercept (Enbrel), an Amgen/Pfizer product, biosimilar developers have seen court defeats to their patent objections that may push back the first biosimilar arrival for this drug until 2029.
With the recent approval of an adalimumab (Hulio) biosimilar, a drug developed by Fujifilm Kyowa Kirin Biologics and commercialized in multiple countries by Mylan, there have been 2 biosimilars approved so far this year.
Currently, there are 28 US-approved biosimilars, 17 of which have been launched on this market.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Similar Survival, Safety for Bevacizumab Biosimilar vs Originator in Colorectal Cancer
February 8th 2025A retrospective observational study found no significant differences in progression-free survival or safety in patients with colorectal cancers in Japan treated with ABP 215, Amgen’s bevacizumab biosimilar, or reference bevacizumab (Avastin), and estimated cost savings of 800,000 Japanese yen (approximately $5100) per patient with the biosimilar.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
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.
A Banner Year for Biosimilars: The 19 FDA Approvals From 2024
January 21st 2025In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.