Biocon receives USFDA approval for biosimilar of Neulasta

Fulphila, a biosimiliar indicated to reduce risk of infection in patient with non-myeloid cancer, developed by Mylan-Biocon received approval of the US drug regulator.

The medication is the first biosimilar to Neulasta. It will serve as an affordable alternative treatment option to Neulasta. Fulphila is approved to reduce the risk of infection in patients treated with chemotherapy in non-myeloid cancers.

Neulasta is Amgen Inc’s blockbuster drug. In the US market, Neulasta has sales of US$4.2 billion for FY2018, as per data available with IQVIA.

Developed in collaboration with Mylan, this is Biocon's second biosimilar to receive USFDA approval. Earlier, in December 2017, the company had received FDA's approval for Ogivri (trastuzumab), a biosimilar to Roche's Herceptin Q.

Reacting to this development, in Tuesday's early morning session, the stock of Biocon was trading at up by more than 3 per cent. At 9:57 hours, the stock was at Rs. 665.05 per share, up 1.67 per cent, when the benchmark index BSE Sensex was at 34,953.15, down by 58.74 point or 0.17 per cent.