Biocon surges 14% on USFDA nod for biosimilar of cancer drug

Herceptin

Mylan and Biocon announced that US Food and Drug Administration (FDA) have approved Mylan's Ogivri, a biosimilar to Herceptin, co-developed with Biocon.

Mylan said in a statement Ogivri is the first biosimilar in its collaboration with Biocon to get U.S. approval, and while it has kept quiet about its commercialisation plans some analysts have suggested it will start making revenues from the drug in 2019 - the year in which Roche's USA patent on Herceptin expires. Biosimilar drugs are identical copy of highly complex biologic drugs that claim to have the same efficacy as the innovator's version. Mylan and Biocon's biosimilar is called Ogivri (trastuzumab-dkst) and follows a back and forth of delays with regulators over manufacturing issues at a plant in India.

Scott Gottlieb, FDA Commissioner (MD, USA), concluded: "The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs".

Meanwhile, in the EU, Mylan withdrew its application for the Herceptin biosimilar, though just yesterday, the companies said that the European Medicines Agency has since re-accepted its application.

The FDA's decision was based on data showing the structural and functional similarities between Ogivri and Herceptin, in addition to preclinical and clinical trial data showing similar safety and effectiveness.

"Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon's joint portfolio approved in the US", Biocon said in a statement.

"The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the U.S. healthcare system", said Mylan's chief executive Mylan chief executive Heather Bresch.

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