Biocon hits fresh 52-week high as biosimilar drug Pegfilgrastim gets USFDA nod

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26 Aug, 2025 12:21

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Biocon rallied over 6 percent in morning trade on Tuesday to hit a fresh 52-week high of Rs 695 on BSE after Mylan N.V. and Biocon announced on Tuesday that the U.S. Food and Drug Administration (USFDA) has approved Mylan’s Fulphila, a biosimilar to Neulasta, which was co-developed with Biocon.

The drug is used to treat low count of neutrophils in patients undergoing chemotherapy in certain types of cancer, the company said in a statement to exchanges.

Biocon pared some gains and was trading 2.5 percent higher at Rs 670.85 at 09:25 AM.

Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon’sjoint 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.

"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," Dr. Arun Chandavarkar, CEO & Joint Managing Director at Biocon said.

"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," he added.