Biocon & Mylan's Biosimilar Trastuzumab Gets ANVISA Nod

Biocon and Mylan N.V have announced that its biosimilar trastuzumab 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 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.

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 our 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.