Tony Hagen is senior managing editor for The Center for Biosimilars®.
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.