Mylan and Biocon Gain Brazilian Regulatory Approval for Trastuzumab Biosimilar

Mylan and Biocon ended 2017 with more positive news for their biosimilar program; on December 29, 2017, the partnership announced that Brazil’s National Sanitary Surveillance Agency (ANVISA) had approved their trastuzumab biosimilar for the treatment of overexpressing HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive advanced gastric cancer. The drug, which will be sold under the brand name Zedora, is the first biosimilar trastuzumab to be approved in Brazil.

In a statement, Mylan’s CEO, Heather Bresch, highlighted the fact that the biosimilar could bring about greater patient access to biologic treatment for cancer: “The number of women diagnosed with breast cancer in Brazil is increasing. Sadly, many of the women with HER2-positive metastatic breast cancer in Brazil do not have access to [trastuzumab] through the country's public health system. The approval of Zedora…is an important step in our efforts to increase access to this critical product for patients with certain breast and gastric cancers and reduce the overall financial burden for health systems around the world."

The ANVISA approval was granted through Mylan and Biocon’s Brazilian partner, Libbs Farmaceutica. Libbs is a pharmaceutical company that currently markets approximately 90 drug brands in 200 presentations for indications in gynecology, neurology, cardiology, oncology, and dermatology. The company’s biotechnology unit, Biotech, launched in 2016, is responsible for the production of its monoclonal antibodies.

Earlier in December 2017, the Mylan and Biocon gained FDA clearance for the same drug, which will be marketed in the United States under the brand name Ogivri. The FDA approval was the first for a biosimilar trastuzumab, and the second for an anticancer therapy in the United States.

The partnership has also re-submitted an application for the drug to the European Medicines Agency (EMA) after its first application was withdrawn as the companies awaited re-inspection of a manufacturing facility in India. Should the Mylan and Biocon product gain EMA clearance, the drug will eventually compete with Celltrion’s recently EMA-approved biosimilar trastuzumab, Herzuma, as well as Samsung Bioepis’ EMA-approved product, Ontruzant.