Reality Check: Biosimilar cheer for Biocon



The stock of Biocon surged as much as 16 per cent last Monday. This was after US drug regulator FDA approved Mylan’s Ogivri — a biosimilar version of Roche’s breast-cancer drug Herceptin.

Mylan and Biocon are partners for biosimilar products. Mylan will market Ogivri in the US, Europe and other key markets while Biocon will manufacture and supply the product on a cost-plus-profit sharing basis. The innovator drug Herceptin has annual sales of $2.6 billion in the US and global sales of $6.9 billion.

Mylan and Biocon are the only players to have settled with Roche for launch of the biosimilar in the US and Europe. The approval has increased hope for further approvals from the Biocon-Mylan biosimilar pipeline. Awaiting approval is the Neulasta biosimilar (oncology) that has annual sales of $3.9 billion in the US.

Biocon is the first Indian pharmaceutical company to receive approval for biosimilar in the US, attesting to its capabilities in the space.

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