Recently it was announced that the BLA (biologics license application) for a product purported as biosimilar to branded trastuzumab, and indicated to treat certain HER2-positive breast cancers, was accepted by the FDA. Mylan and Biocon submitted the BLA for MYL-1401O; its acceptance by the FDA is an important step forward for providing U.S. patients with this type of breast cancer an additional treatment option, according to Mylan President, Rajiv Malik.
According to reports, this BLA acceptance is Mylan and Biocon’s first U.S. regulatory submission through the 351(k) pathway. Biocon CEO and Joint Managing Director, Dr. Arun Chandavarkar, said Mylan and Biocon are delighted the BLA was accepted by the U.S. Food & Drug Administration, and that the acceptance is a major milestone in the collaboration of the two companies. Malik said the collaboration is an effort to make affordable, high-quality biosimilars more accessible to patients worldwide.
Every year approximately 2 million women around the world are diagnosed with breast cancer, with 20% to 30% of the primary diagnoses found to be HER2-positive. An aggressive form of metastatic breast cancer, HER2-positive means the cancer tests positive for HER2, a human epidermal growth factor receptor.
Mylan and Biocon hope the companies’ partnership in this biosimilar effort will provide effective treatment for woman diagnosed with this aggressive form of breast cancer. Mylan holds exclusive commercial rights for the proposed biosimilar trastuzumab in Australia, Canada, in the European Free Trade Association Countries and European Union, Japan, New Zealand, and the U.S., while the two companies share commercialization rights for the biosimilar trastuzumab throughout the rest of the world.
Biosimilar drugs are those that have a chemical structure very similar to a biologic medical product, and are nearly identical to an original product made by a different company. In this case, MYL-1401O is a biosimilar for trastuzumab, a chemotherapy for treatment of breast, stomach, and esophageal cancer, also known under the brand Herceptin.
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