Biocon & Mylan’s biosimilar ‘Trastuzumab’ gets approval from Brazilian regulator

Co-developed by Biocon and Mylan, this is the first biosimilar Trastuzumab to be approved in Brazil and is indicated for the treatment of overexpressing HER2­positive metastatic breast cancer. Product will be marketed by the Libbs Farmaceutica (Libbs), a leading Brazilian pharmaceutical company


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

Co-developed by Biocon and Mylan, this is the first biosimilar Trastuzumab to be approved in Brazil and is indicated for the treatment of overexpressing HER2­positive metastatic breast cancer, HER2­positive early stage breast cancer and HER2­positive 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: “This marks the first approval for a biosimilar Trastuzumab by Brazil’s ANVISA and demonstrates our commitment to provide access to high-quality and affordable biologics to patients across the globe. 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. We are committed to make global impact with our affordable antibodies against cancer.”

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. 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.”

Alcebíades de Mendonça Athayde Júnior, Libbs CEO, said:“The approval of Zedora will allow us to bring this first-of-its-kind biosimilar Trastuzumab to breast and gastric cancer patients in Brazil. Biosimilar Trastuzumab, co-developed by Biocon and Mylan, can help expand cancer−patient access to more affordable treatment and contribute to significant savings to Brazil’s healthcare system. Zedora will strengthen our current product portfolio as a new generation targeted therapy that can benefit cancer patients immensely.”

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.

This is a significant approval as it sets the stage for the entry of biosimilar Trastuzumab into Brazil, which is among the top three emerging markets globally for Trastuzumab. The pharmaceutical market in Brazil is predicted to grow to US$30 billion in 2021 from US$26 billion in 2016. (Source:GlobalData)

Breast cancer is the leading cause of cancer death in women in Brazil, where new cases are estimated to be over 57,000 annually, with an estimated incidence of 56 cases per 100,000 women. It is the second-most common type of cancer that affects women in Brazil, after non-melanoma skin cancer. Trastuzumab is now included on the WHO list of essential medicines.

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.