Mylan-Biocon's Biosimilar Cancer Drug Comparable To Roche's Herceptin: Study

(RTTNews) - Breast cancer medicine MYL-1401O, the proposed biosimilar Trastuzumab co-developed by drug major Mylan N.V. (MYL) and its Indian partner Biocon Ltd., is comparable to Roche Holding AG's branded Trastuzumab, a study, dubbed HERITAGE, confirmed.

Trastuzumab, sold under the brand name Herceptin, is indicated for the treatment of HER2-positive metastatic breast cancer patients, as well as for adjuvant treatment of HER2 overexpressing breast cancer and metastatic gastric cancer.

In the HERITAGE study, where patients were randomized to receive either MYL-1401O or Herceptin with docetaxel or paclitaxel for a minimum of eight cycles, MYL-1401O has been found to have comparable safety and efficacy as that of Herceptin (branded Trastuzumab).

The data was presented at the 2016 American Society of Clinical Oncology or ASCO Annual Meeting in Chicago.

Mylan President Rajiv Malik said, "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."

Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon, noted that the trial will enable regulatory filings of the product in the developed markets.

Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products, and the proposed biosimilar Trastuzumab is one of the six biologic products co-developed by them.

For the proposed biosimilar Trastuzumab, Mylan has exclusive commercialization rights in the U.S., 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.

Until now, two biosimilar drugs have received FDA approval namely Novartis AG's Zarxio, a biosimilar to Amgen Inc.'s Neupogen, and Celltrion Inc.'s INFLECTRA, which is a biosimilar to Johnson & Johnson's Remicade.

In India, Biocon shares are currently gaining 3.6 percent to trade at 728.35 Indian Rupees.