February 23, 2018

Biosimilar treatment for certain breast and stomach cancers approved by FDA

05 December 2017, 10:18 | Winifred Adams

Mylan and Biocon are among a host of biosim developers that are working to grab a piece of Roche’s global cancer fortunes

Mylan and Biocon are among a host of biosim developers that are working to grab a piece of Roche’s global cancer fortunes

This milestone secured a clear pathway to commercialize Mylan's biosimilar to Herceptin in various markets globally, stated the company release.

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

The biosimilar - developed by Mylan and Biocon and called Ogivri (trastuzumab-dkst) - has been approved by the FDA for HER2-positive breast or metastatic stomach cancer, the same indications as Herceptin which brought in nearly $7bn in sales past year, around $2.5bn of that total from the U.S. market. "This is especially important when it comes to diseases like cancer, that have a high cost burden for patients", said FDA Commissioner Scott Gottlieb.

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

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Ogivri's clearance is based on a review of evidence that included extensive structural and functional characterisation, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates its biosimilarity to Herceptin (trastuzumab).

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

Ogivri is first FDA-approved biosimilar to Herceptin It has almost tripled its value since the beginning of the past year. Biocon expects revenue from its biologics portfolio in regulated markets such as the United States and Europe to kick in from next fiscal. It will allow us to bring this important biosimilar, expanding cancer-patient access to more affordable treatment.

Annual sales of the Roche's cancer medicines - Rituxan, Herceptin and Avastin - top $21 billion, or more than half of its pharmaceuticals business, but are under threat as their biosimilar versions get approval.

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