Mylan-Biocon Get USFDA Nod for Biosimilar Pegfilgrastim

Mylan-Biocon combine have notched up their second biosimilar in the US following the regulatory approval given to Fulphila, Mylan’s biosimilar version of pegfilgrastim, originally sold by Amgen under the brand name Neulasta.

Mylan pipped other competitors in the race for this drug in the US market, when it received the US FDA’s approval for Ful-phila, a biosimilar it co-developed with Biocon. The product is used to treat fever and other signs of infection in patients treated with chemotherapy in certain types of cancer.

Last December, the Mylan-Biocon combine had received the USFDA approval on their biosimilar version of Roche’s breast cancer drug trastuzumab.

A US launch of Fulphila is being lined up, but an India timeline for the product is not yet on the radar. Explaining the significance of the US launch, Mylan President Mr. Rajiv Malik said the product would address affordability and access concerns in the market. The biosimilar will be produced at Biocon’s Bengaluru facility and all FDA related concerns on the plant are “behind us”, Mr. Malik said.