Mylan, Biocon's PhIII success for Herceptin knockoff threatens anchor drug for Roche

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Generics powerhouse Mylan ($MYL) and its partners at Biocon have wrapped a successful late-stage study for their copycat version of Roche’s Herceptin, pointing them toward regulatory filings aimed at eventually carving into a multibillion-dollar drug franchise.

Investigators say there was no significant difference between MYL-1401O and Herceptin in terms of efficacy and safety in treating breast cancer.

“To our knowledge, this is one of the first clinical trials to show equivalency of a trastuzumab biosimilar to the branded cancer drug,” said lead study author Dr. Hope Rugo, a professor of medicine at the University of California, San Francisco.

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But it won’t be the last. Pfizer ($PFE) and Samsung Bioepis both have late-stage trials for their own biosimilar versions of Herceptin, one of the original pioneers in a generation of targeted cancer treatments.

Biosimilars have just begun to break into the U.S. market, starting to pit these discounted therapies against some major franchises. In Europe, biosimilars have been making headway for years now, and a recent survey of physicians found that over the last few years their experience with a generic version of Merck’s ($MRK) Remicade has helped make them more confident in using these new knockoffs.

Close to half of all physicians now consider the biosimilar alternative to Remicade as interchangeable with the original, and with discounts of up to 45% for the copycats, there has also been growing enthusiasm about the prospect of saving money. Mylan and Biocon are hoping to repeat that experience with MYL-1401O. And as more knockoffs arrive, the discounts are likely to grow.

Their arrival could topple an anchor franchise for Roche ($RHHBY). Herceptin earned close to $6.6 billion in 2015, its send biggest earner after Rituxan.

“Trastuzumab has markedly improved survival of women with HER2-positive breast cancer, but many women around the world can’t benefit from trastuzumab due to its high cost,” added Rugo. “We hope that the introduction of biosimilars will expand patient access to this effective drug, which has already benefited the lives of thousands of people across the globe.”

The objective response rates at 24 weeks were 69.6% with MYL-1401O vs. 64% with trastuzumab, the companies reported. The immunogenicity and safety were comparable between treatment groups. The rates of serious adverse events were 36% in the trastuzumab group and 38% in the MYL-1401O group. The most common serious side effect was low blood counts (neutropenia), and there was no difference in measures of cardiac function between the two arms. There were also four treatment-related deaths in both groups.

- here's the release

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