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,” Mylan President Rajiv Malik said today.
NEW DELHI, Jun 4: Global pharma major Mylan Inc, and Biocon have confirmed the efficacy and safety of MYL-1401O, a proposed biosimilar trastuzumab co-developed by the firms, in comparison to Roche’s branded Herceptin used for treatment of cancer.
The companies will present data from a clinical study during the American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago from June 3-7, Biocon said in a statement.
“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,” Mylan President Rajiv Malik said today.
There is an urgent, unmet need for more affordable versions of biologic products and through “our collaboration with Biocon we are well-positioned to be at the forefront to help deliver these complex products to patients around the world,” he added.
Trastuzumab is indicated for treatment of a type of breast cancer, Biocon said.
“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,” Biocon Chairperson and MD Kiran Mazumdar Shaw said.
The trial will enable regulatory filings of the product in the developed markets, she added.
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.
In April this year, the Delhi High Court had prevented Biocon from calling its breast cancer medicine trastuzumab as a biosimilar of Roche’s Herceptin but was allowed to market and advertise their products under the name CANMAb or Bmab-200 or Hertraz. Herceptin, a breast cancer treatment drug, is registered brand of Swiss pharma major Roche.