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How Mylan Is Taking On One of the World’s Top Breast Cancer Drugs

Herceptin Approved For Treatment Of Scottish Breast Cancer PatientsHerceptin Approved For Treatment Of Scottish Breast Cancer Patients
The drug combo's benefit was modest.Photograph by Jeff J Mitchell—via Getty Images

Drugmaker Mylan hopes to challenge one of the world’s top breast cancer treatments, Roche/Genentech’s Herceptin, with a copycat drug the company says will be less pricey.

The firm unveiled new late-stage clinical trial data showing that its biosimilar version of Herceptin produces efficacy and safety responses in patients comparable to the original branded product during the ongoing American Society of Clinical Oncology (ASCO) annual meeting in Chicago.

Biosimilars, or generic copycats of pricey biologic drugs, are relatively new to the United States. The FDA has approved just two of the products: Novartis’ (NVS) Zarxio, a biosimilar of Amgen’s (AMGN) bone marrow booster Neupogen; and Celltrion/Pfizer’s (PFE) Inflectra, a generic of Johnson & Johnson’s (JNJ) anti-inflammatory medication Remicade.

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But Mylan (MIL) may become the first company to file for a biosimilar of an oncology treatment—one that brings in $6.8 billion in annual sales.

“As one of the first companies in the industry to successfully complete a confirmatory efficacy and safety study comparing a proposed biosimilar to a branded cancer drug, this is a significant milestone for Mylan’s biosimilar program,” said Mylan President Rajiv Malik in a statement.

“We’re pleased that ASCO has recognized the importance of biosimilars in advancing cancer care and the significant role they will play in providing patients greater access to affordable treatment,” he added. Biosimilars are often offered at significant discounts to their originator products.

Mylan has stated that it plans to file its biosimilar with the FDA this year, even though Herceptin doesn’t lose patent protection in the U.S. until 2019.

Some branded biologic makers (including Merck and Amgen) have already started working on their own biosimilars, sensing a rapidly growing new market. But Roche/Genentech (RHHBY) doesn’t plan to follow suit.

“At the end of the day, at some point, biosimilars will come into the market,” said Daniel Chen, Global Head of Cancer Immunotherapy Development at Genentech, when asked about Mylan’s Herceptin biosimilar by Fortune. “I think the key piece here is that if something is going to be called a biosimilar, it really is similar. For us, biosimilars are not a place where we’re focusing. For us, we want to concentrate on developing new approaches.”