Sunday, 10 December, 2017

Mylan gets first biosimilar Herceptin OK from FDA

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
Melissa Porter | 04 December, 2017, 18:15

Shares of Biocon rallied 15% after the drug regulator, USFDA approves Mylan and Biocon's co-developed product, Ogivri, the first biosimilar for Trastuzumab for treatment of HER2-Positive breast and gastric cancers. "This is especially important when it comes to diseases like cancer, that have a high cost burden for patients".

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.

Shares of Biocon hit a record high on US FDA approval for generic cancer drug Ogivri.

Amgen/Allergan, Pfizer, and Samsung Bioepsis are also developing biosimilar Herceptin products for the U.S. and global markets, but analysts have suggested that Roche's brand will not see a dramatic reduction in sales after the rivals launch, in part because use of the drug in combination with newer HER2 drug Perjeta (pertuzumab) is on the rise.

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

"This approval represents a landmark achievement for the Biocon-Mylan collaboration and is an important endorsement of our development and manufacturing capabilities in the area of monoclonal antibodies", said Arun Chandavarkar, chief executive officer and joint managing director of Biocon.

Shares of Biocon settled with gains of 15 per cent on the bourses, after the company said it has received regulatory approval to market a biosimilar of cancer drug Herceptin in the United States, following which the market capitalisation of the company improved by Rs 4,020 crore. It is already approved in 19 countries around the world, including India, "thus providing increased access to this more affordable biologic for cancer patients".