Biosimilar Trastuzumab, co-developed by Biocon Ltd. and Mylan N.V. 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.
Dr Arun Chandavarkar, CEO and Joint Managing Director, Biocon, said: “Cancer patients in India and some emerging markets have benefited with our Trastuzumab and the approval in Brazil will enable affordable access to this critical biologic therapy for the treatment of HER2-positive breast and gastric cancers in the country.”
Mylan CEO Heather Bresch commented: “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.”
Biocon and Mylan are responsible for the development of biosimilar Trastuzumab. While currently the trastuzumab will 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 (PDP). Libbs have already built the biotechnological site to manufacture Zedora for the Brazilian market.
Earlier this month, Biocon and Mylan marked a major milestone with the U.S. Food and Drug Administration approval of their biosimilar Trastuzumab. 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.