Biocon, Mylan Get U.S. FDA Approval For Biosimilar To Roche’s Cancer Drug 

Shares of Biocon Ltd. climbed as much as 14 percent and were headed for a record since April 2004, after the biopharmaceutical firm and Mylan NV became the first drugmakers to get the U.S. Food and Drug Administration's approval for a biosimilar used to treat breast and stomach cancers.

Mylan-Biocon's trastuzumab, to be sold under the name Ogivri, is a biosimilar to Roche Holdings AG's Herceptin and the first biosimilar from the joint portfolio to be approved in the U.S., Biocon said in its press statement. Herceptin had U.S. sales of more than $2 billion for the 12 months ending Sept. 30, according to healthcare information provider IQVIA.

Biosimilar medicines are deemed by FDA to be highly similar to an already-approved biologics product. Biologics are made from living cells, making them difficult to replicate with precision.

Milestone For Mylan-Biocon Partnership

Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. Ogivri is one of the six biologics products co-developed by the companies.

The FDA approval is a “crowning moment” that puts the two partners in an exclusive league of global biosimilar players, Kiran Mazumdar-Shaw, the chairman and managing director of Biocon said in a press release.

Mylan has exclusive commercialization rights for Ogivri in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

Commercial Launch Timeline

The commercial launch of the drug will likely happen sometime in 2019 as per settlement with the innovator Roche, and the full financial impact will probably be visible from the financial year 2020-21, according to IDFC Securities Ltd.

The FDA approval will enable Biocon to get regulatory approval in few emerging markets, according to Motilal Oswal Financial Services.

Also Read: U.S. Drug Regulator Seeks More Data From Biocon On Cancer Treatment Biosimilar