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Regular-article-logo Sunday, 05 April 2026

US fillip for Biocon drug

India's Biocon has received approval in the US for a biosimilar it has developed with Mylan to treat cancer patients. Both the companies announced that the US Food and Drug Administration (FDA) has approved the drug to be marketed under brand nameFulphila.

Our Special Correspondent Published 06.06.18, 12:00 AM

Mumbai: India's Biocon has received approval in the US for a biosimilar it has developed with Mylan to treat cancer patients. Both the companies announced that the US Food and Drug Administration (FDA) has approved the drug to be marketed under brand nameFulphila.

It is a biosimilar to Amgen's Neulasta, which had sales of $4.2 billion for the 12 months ending March 31, 2018, in the US.

A biosimilar is a product that is highly similar to a biological drug already approved by regulators such as the US FDA. Fulphila will help patients with non-myeloid cancers reduce the risk of infection following chemotherapy. It will be the first biosimilar for pegfilgrastim (the core ingredient for Neulasta and Fulphilia) available in the US.

A joint press statement said Mylan will be launching Fulphila in the coming weeks.

"It (Neulasta) represents an important milestone for patients. FDA's approval of this product, as well as the agency's continued focus on biosimilars, mark crucial steps towards lowering treatment costs and providing alternative options for patients," Mylan CEO Heather Bresch said.

The news led to the shares of Biocon surging on the bourses on Tuesday. However in a volatile trade, the stock gave up all its gains and ended in the red. Biocon hit an intra-day high of Rs 695 on the BSE, a rise of over 6 per cent. The scrip surrendered all these gains and settled at Rs 607.70, a drop of 7.09 per cent over the last close.

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