Mylan seeks FDA approval for biosimilar Herceptin copy

FDA sign

Mylan ($MYL) has filed for FDA approval of its biosimilar copy of Roche’s ($RHHBY) Herceptin. The submission tees up Mylan and its partner Biocon to start chipping away at a cornerstone of Roche’s business while advancing their own attempts to establish a portfolio of biosimilars in the U.S.

Biocon and Mylan are hoping to win approval to use their biosimilar to treat certain HER2-positive breast and gastric cancers. To make its case, Mylan has included results from a slate of studies, including a confirmatory efficacy and safety trial. That study, data from which were released in June, showed the biosimilar can hold its own against Herceptin in terms of objective response rates, immunogenicity and safety.

Getting a submission to FDA puts Mylan and Biocon at the front of a clutch of companies seeking to cannibalize the $6.6 billion Herceptin made for Roche last year. As in Europe, the partners think they are the first to submit for approval of a biosimilar copy of Herceptin.

Other companies are close behind. South Korea’s Celltrion filed for approval in Europe shortly after Mylan, as did its compatriot Samsung Bioepis. Amgen ($AMGN) and Allergan ($AGN) posted Phase III data on their contender within six weeks of Biocon and Mylan. Pfizer ($PFE) is also in the running.

The potential for a string of Herceptin biosimilars to come to market in quick succession could drive down prices. When Pfizer set the price for its copy of Johnson & Johnson’s ($JNJ) Remicade last month, it knocked 15% off the branded list price. If Mylan is the first company to get a Herceptin copy to market, it may pursue a similar pricing strategy, insulating Roche from the worst effects of biosimilar competition. But such high prices are tipped to crumble as competition heats up.

For Mylan and Biocon, the Herceptin biosimilar is a test case for the globalization of their strategy. The partners initially targeted emerging markets, leading to the approval of their Herceptin copy in India and 10 other countries. Now, focus is shifting to the U.S. and Europe. Another five biosimilars are advancing down the companies’ joint pipeline.