Biosimilars

Roche and Mylan settle a scrap over Herceptin, clearing path to a global launch of a knockoff drug

Heather Bresch, CEO of Mylan

Two weeks ago Roche shares jumped on the news that the pharma giant had scored winning Phase III data supporting the combination of Herceptin and Perjeta in fighting early-stage breast cancer. And today, Roche and Mylan are announcing that they’ve agreed to a settlement of their long-running dispute over a biosimilar of Herceptin, leaving Mylan with boasting rights for its shot at becoming the first company to get a knockoff onto the US market.

Mylan and Roche hammered out a global licensing pact that gives Mylan launch dates for markets around the world. But the companies are keeping the schedule under wraps. As part of the settlement, Mylan is dropping a legal challenge to two of Genentech’s patents.

From the statement:

Following this settlement and the recent acceptance of Mylan’s application for its proposed biosimilar trastuzumab with the U.S. Food and Drug Administration (FDA), Mylan anticipates potentially being the first company to launch a biosimilar to Herceptin in the US.

Mylan is facing a September 3rd PDUFA date on their knockoff of Herceptin, a megablockbuster for Roche that brought in $6.7 billion last year. The company has managed to stall competitors to its big franchise drug, though, giving it time to maneuver forward with a combo successor that should help keep it highly competitive. Just a week ago Roche lost a three-year running fight with Mylan and Biocon over its attempt to break into the key Indian market.

Roche’s Dan O’Day said earlier that he didn’t believe a biosimilar of Herceptin would reach the US market before the fall of this year.

Roche’s position now will lean heavily on data from its APHINITY study, which demonstrated positive data for the combination of Perjeta and Herceptin in post-surgery patients.

Amgen and Novartis, meanwhile, have been sparring over the rules on introducing new biosimilars. Legislation requires a 180-day notice of sales before biosimilar marketing can start, and Novartis wants to supply the notice ahead of a formal approval to allow for a quick start. Amgen and opponents, though, argue that the notice should be only allowed after an approval, in order to avoid market “chaos.” And both sides are taking the case, which includes a dispute over requiring biosimilars manufacturers to disclose applications, to the Supreme Court next month.

The settlement is big news for Mylan, which developed the biosimilar with India’s Biocon. Mylan has sole marketing control in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries, with Biocon holding co-sales rights in the rest of the world.

Mylan CEO Heather Bresch commented:

There is an unmet need for access to more affordable versions of biologic products such as trastuzumab. We look forward to enhancing access to this important treatment option, which complements our comprehensive cancer care offerings, in the U.S. and around the world. With 16 biosimilar products in development, we believe Mylan has one of the industry’s broadest portfolios of biosimilars and that we will be a leader in bringing high-quality biosimilar products to market given our ability not only to develop and manufacture such complex products, but also to navigate the intricate regulatory and legal environment and successfully commercialize these products on a global basis.


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RAPS Regulatory Convergence 2017