Biosimilar Trastuzumab, co-developed by Biocon and Mylan, has been approved by ANVISA, the Brazilian regulatory agency, through their partner Libbs Farmaceutica (Libbs), a leading Brazilian pharmaceutical company.

This is the first biosimilar Trastuzumab to be approved in Brazil and is indicated for the treatment of overexpressing HER2-positive metastatic breast cancer, HER2-positive early stage breast cancer and HER2-positive advanced gastric cancer. Libbs will commercialize the product in Brazil under the brand name Zedora, which will provide affordable access to a cutting-edge biologics therapy for patients in Brazil.

Mylan’s chief executive officer, Heather Bresch, said, “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, Brazil’s first Trastuzumab biosimilar, 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.”

Biocon and Mylan are responsible for the development of biosimilar Trastuzumab. While it will initially be manufactured by Biocon and supplied to Libbs for commercialization in Brazil, over a period of time the technology will be transferred to Libbs and the public partner Butantan through a Productive Development Partnership. 

Biocon and Mylan’s biosimilar Trastuzumab is also under review by regulatory authorities in Australia, Canada, Europe and several additional markets. It is already approved in several other countries around the world, including India, where it is providing increased access to this more affordable biologic for cancer patients.