On occasion, we profile some biosimilar manufacturers about whom our readers may not be as familiar as the large players like Sandoz, Amgen, and Samsung Bioepis. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this post, we highlight a Bridgewater, NJ-based company, Amneal Pharmaceuticals.
Amneal was founded in 2002 as a generic pharmaceutical manufacturer by two brothers, Chirag and Chintu Patel. The company produces more than 250 generic drugs, four specialty pharmaceuticals, and has three biosimilars under its belt.
Why you may be hearing more about this company: Amneal received FDA approval for its filgrastim biosimilar (Releuko™) on March 1, and it is awaiting decisions on a pegfilgrastim biosimilar and a bevacizumab biosimilar as well. The two granulocyte colony–stimulating factors are being developed in conjunction with Kashiv Biosciences. In 2021, Amneal acquired the Kashiv subsidiary Kashiv Specialty Pharmaceuticals. The bevacizumab biosimilar (MB02) is the result of a partnership with mAbxience. Amneal filed a 351(k) application for this product in June 2021.
Amneal may be very well positioned for the biosimilar arena. It is primarily a generic drug manufacturer that is seeking to enter highly competitive biosimilar environments. Amneal is well familiar with the multisource generics model, which generally yields lower revenues than conventional branded agents. For example, the filgrastim market in the US is about $400 million, with now three biosimilars, one follow-agent, and the reference manufacturer. Yet a fairly small portion of these revenues would contribute to Amneal’s sustained interest in biosimilars, whereas it might be insufficient for other drug makers. Of course, US bevacizumab sales are far more attractive.
Of further note, Sean McGowan, formerly of AmerisourceBergen, has joined Amneal Pharmaceuticals as Vice President, Sales and Marketing, to help get the commercialization of these biosimilar products off to a running start.