Biocon share price hits lifetime high on USFDA approval to cancer drug; stock jumps 6%

Biocon share price rallied over 6 per cent to hit its lifetime high after the pharma major and its global partner Mylan received USFDA nod for a biosimilar of a drug used to treat cancer.  The stock gained as much as 6.25 per cent to its all-time high of Rs 695 on the BSE. 

"The US Food and Drug Administration (FDA) has approved Mylan’s Fulphila™ (pegfilgrastim-jmbd), a biosimilar to Neulasta® (pegfilgrastim), co-developed with Biocon. 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," said Biocon in a filing to BSE. 

Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon’s joint portfolio approved in the US 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.

"It’s a moment of great pride to be the first to receive approval for a biosimilar pegfilgrastim by the USFDA. This important milestone comes soon after our achievement of being the first to receive USFDA approval for biosimilar trastuzumab," said Arun Chandavarkar, CEO & Joint Managing Director, Biocon. 

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"It represents a further endorsement of the Biocon-Mylan partnership’s ability to successfully develop complex molecules to exacting quality and regulatory standards. This approval expands our oncology portfolio for the benefit of cancer patients and supports our mission to improve access to high quality, affordable biopharmaceuticals globally," Chandavarkar added.

Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products.