Biocon, Mylan Biosimilar Receives Brazilian Regulatory Approval
ANVISA, the Brazilian regulatory agency, has now approved Biocon and Mylan’s biosimilar Trastuzumab to be commercialised in the country by Libbs under the brand name Zedora.
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.
Biocon CEO and joint managing director Dr Arun Chandavarkar 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 benefitted 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.”
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.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 cancerpatient 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.“
