Mylan, Biocon upbeat on trial data involving breast cancer drug

US drugmaker Mylan and Biocon have said that the recent trial data has further confirmed the efficacy and safety of their breast cancer drug MYL-1401O, a development that validates the quality of biosimilar drugs for cancer patients.

These claims were presented through a study paper at the 2016 American Society of Clinical Oncology (ASCO) annual meeting in Chicago. MYL-1401O is a biosimilar product co-developed by the companies and it competes with the innovator Roche’s branded Herceptin (trastuzumab).

Both Mylan and Biocon market their versions of trastuzumab in India at a price less than the innovator. The latest trial data comes even as they are locked in a case over the drug with Roche.

Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. The proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace, the company 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 programme,” said. There is an urgent need for more affordable versions of biologic products and through our collaboration with Biocon we are well-positioned, he added.

For Biocon, this development comes on the back of some success in its biosimilars business. In the 2016 fiscal, Biocon’s insulin Glargine became the first biosimilar from India to be approved in Japan and Chairperson and Managing Director Kiran Mazumdar Shaw had said that this opened up opportunities in the emerging markets such as South Africa, Russia and Brazil.

“The positive outcomes of the global phase-III clinical study with our proposed biosimilar trastuzumab for HER2-positive breast cancer patients are a significant milestone in our joint biosimilars development program with Mylan,” Shaw added. The trial will enable regulatory filings of the product in the developed markets, she added.

The trial data comes as a shot in the arm for Biocon and Mylan who were dragged to the Delhi High Court by the Indian arm of Swiss drugmaker Roche seeking an injunction on marketing and sale of Trastuzumab by both the companies.

At the core of the case is whether the products can be called a biosimilar version of the innovator drug. Unlike generically similar versions of allopathic medicine, a bio-similar is described as a “highly similar” version of a biological drug, and its manufacturing involves just as complex a process.

Roche and its licensed partners market Trastuzumab in India under brand names Herceptin, the patent for which had lapsed in 2013. However, in April this year, the Delhi High Court allowed Biocon and Mylan to continue manufacturing and marketing their breast cancer drug under brand names CANMAb and HERTRAZ.

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