2 January 2018 - - Trastuzumab, a biosimilar co-developed by Bengaluru, India-based biopharmaceutical company Biocon Ltd. (BSE: 532523) (NSE: BIOCON) and Hertfordshire, England-based global pharmaceutical company Mylan N.V. (NASDAQ: MYL) (TASE: MYL) has been approved by ANVISA, the Brazilian regulatory agency, through their partner Sao Paulo, Brazil-based pharmaceutical company Libbs Farmaceutica, the company said.
Trastuzumab 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.
Biocon and Mylan are responsible for the development of biosimilar Trastuzumab. 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.
Libbs has already built the biotechnological site to manufacture Zedora for the Brazilian market.
Biocon, an emerging global biopharmaceutical enterprise serving customers in over 120 countries, it is committed to reduce therapy costs of chronic diseases like diabetes, cancer, and autoimmune disease.
Mylan offers a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. The company markets products in more than 165 countries and territories.
Libbs, a 100% Brazilian pharmaceutical company, employs around 2500 people. The company invests 10% of its revenue in R and D and innovation. It now has around 90 brands in the market in 200 different presentations distributed across several specialties, including gynecology, central nervous system, cardiology, oncology and dermatology.