Biocon shares hit record high as cancer drug Pegfilgrastim gets USFDA nod

Shares of Biocon hit a record high of Rs 695 per share, up 6% on the BSE in opening deal in otherwise weak market, after the company and its partner Mylan have received nod for their first biosimilar of cancer medicine Pegfilgrastim from the US drug regulator for selling in the American market.

“The United States Food and Drug Administration (USFDA) has approved Mylan’s Fulphila (pegfilgrastim-jmbd), a biosimilar to Neulasta (pegfilgrastim), co-developed with Biocon,” the company said in a press release.

Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells) in patients treated with chemotherapy in certain types of cancer, it added.

Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon’s joint portfolio approved in the U.S. Mylan anticipates launching Fulphila in the coming weeks, representing the first alternative, more affordable treatment option to Neulasta for oncology patients. A suite of patient services also will be available at launch to further support patients and caregivers with treatment, the company said.

At 09:39 am; the stock was trading 1.4% higher at Rs 664, erasing most of its early morning gain. It touched a low of Rs 662 on the BSE so far. A combined 3.3 million shares have changed hands on the counter on the BSE and NSE. The S&P BSE Sensex was trading 0.16% lower at 34,958.