Fulphia, a biosimilar product of the Mylan-Biocon collaboration, has been approved by the FDA to reduce the duration of febrile neutropenia in patients treated with chemotherapy. Febrile neutropenia refers to the signs of infection resulting from a low count of neutrophils, a type of white blood cell.
This marks the second biosimilar approval granted to the collaboration, and the first biosimilar to Amgen’s Neulasta.
Mylan CEO Heather Bresch points out that with drug prices and patient access in the spotlight, an approval like this—an affordable alternative for a drug already on the market—is an exciting development, commenting, “FDA’s approval of [Fulphia], as well as the agency’s continued focus on biosimilars, mark crucial steps towards lowering treatment costs and providing alternative options for patients.”
Mylan has one of the largest biosimilar portfolios in the industry comprised of 20 biosimilar and insulin analog products. They were also the first company to receive FDA approval for a biosimilar to Herceptin, Ogivri, in 2017.
Like many other prominent pharmaceutical companies and collaborations, the Mylan-Biocon collaboration appears to be committed to developing more biosimilar products and making them available to the patients that need them as soon as possible. With the changing attitude towards the healthcare industry as a whole, as well as biosimilars and generics, obtaining the necessary approvals might get a little easier moving forward.
(Source: Mylan)
Filed Under: Drug Discovery
