The US Food and Drug Administration (FDA) on Friday approved Mylan N.V. and Biocon Ltd’s biosimilar for Roche’s drug Herceptin, used in the treatment of breast and metastatic stomach cancer.

Mylan-Biocon’s trastuzumab, to be sold under the name Ogivri, is the first biosimilar approved in the US for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the country for cancer treatment, US FDA said in a release.

A biosimilar is a product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA and has no clinically meaningful differences in terms of safety, purity and potency from the reference product, in addition to meeting other criteria specified by law.

“The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer, that have a high cost burden for patients," said FDA Commissioner Scott Gottlieb. “We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs."

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

Mylan has exclusive commercialization rights for biosimilar Ogivri in the US, 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.

The FDA’s approval of the biosimilar is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Ogivri is biosimilar to Herceptin. Ogivri has been approved as a biosimilar, not as an interchangeable product, the regulator said.

“Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon’s joint portfolio approved in the US. Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of Mylan’s ability to secure global licenses for its trastuzumab product from Genentech and Roche earlier this year," Mylan said in a press release.

“This approval represents a landmark achievement for the Biocon-Mylan collaboration and is an important endorsement of our development and manufacturing capabilities in the area of monoclonal antibodies," said Arun Chandavarkar, chief executive officer and joint managing director of Biocon.

Mylan and Biocon’s biosimilar for Herceptin also is under review by regulatory authorities in Australia, Canada, Europe and several additional markets. It is already approved in 19 countries around the world, including India.

In the US, an estimated 250,000 new cases of female breast cancer and 28,000 new cases of stomach cancer are expected to be diagnosed in 2017 alone. Approximately 20% to 25% of primary breast cancers are HER2-positive. Herceptin had US sales of more than $2 billion in the year ended September, according to global healthcare information provider IQVIA.

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