Health Canada Approves Biocon And Mylan's Ogivri, The First Trastuzumab Biosimilar, For The Treatment Of HER2-Positive Breast And Gastric Cancers

Biocon Ltd. and Mylan N.V. recently announced that Health Canada has approved Mylan’s Ogivri (trastuzumab), a biosimilar to Herceptin (trastuzumab) co-developed with Biocon, for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).

Ogivri is the first trastuzumab biosimilar approved in Canada and the second biosimilar from Biocon and Mylan’s joint portfolio approved in the market. Mylan plansto launch the product this quarter and anticipates potentially being the first company to offer a trastuzumab biosimilar in Canada.

Dr Christiane Hamacher, CEO, Biocon Biologics said, “We are pleased to enable access to Ogivri, a high quality biosimilar trastuzumab co-developed and manufactured by Biocon as an affordable treatment option for HER2- positive breast and gastric cancer patients in Canada. The Health Canada approval granted to Ogivri, will pave the way for its commercialization by our partner Mylan. Thousands of patients in Europe, India and key emerging markets are benefitting from our biosimilar trastuzumab. Biocon Biologics is committed to address unmet patient needs through its high quality, affordable biologics, globally.”

Mylan’s Chief Commercial Officer Tony Mauro commented, “As a global leader in the development of complex products, including biosimilar medicines, we’re pleased to reach this approval milestone for Ogivri and the opportunity to bring this important treatment option to market for Canadian patients with HER2-positive breast and gastric cancers. We look forward to continuing our reimbursement discussions with the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Pan-Canadian Pharmaceutical Alliance (pCPA) to ensure that patients have access to Ogivri.”

Approval by Health Canada was based on robust data from structural and functional characterization using multiple orthogonal techniques, nonclinical studies and pharmacokinetic evaluation in healthy subjects and patients and a safety, efficacy and immunogenicity study in relevant patient populations, which compared Ogivri to Herceptin. The data demonstrated that Ogivri is highly similar to Herceptin with no clinically meaningful differences in terms of efficacy, safety, purity and potency.

Biocon and Mylan’s trastuzumab biosimilar is currently approved in more than 65 countries around the world, including the U.S.

About Biocon and Mylan Partnership

Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. Our biosimilar to Herceptin is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the product in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights for the product in the rest of the world.

About Biocon

Biocon Limited, publicly listed in 2004, is a fully-integrated, innovation-led global biopharmaceutical company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. The Company has developed and commercialized a range of Biosimilars (Monoclonal Antibodies, Pegfilgrastim, rh- Insulin and Insulin Glargine), Novel Biologics and differentiated Small Molecules in India and Key emerging markets. It has a large portfolio of biosimilars under global clinical development with three of these commercialized in the developed markets of EU, U.S. and Japan. It has promising novel assets in immunotherapy under development. Some of its key brands are INSUGEN (rh-insulin), Basalog One (prefilled Glargine pen), CANMAb (Trastuzumab), KRABEVA (Bevacizumab), BIOMAb-EGFR (Nimotuzumab) and ALZUMAb (Itolizumab). For more information, visit www.biocon.com.

About Mylan

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer 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. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. For more information, visit Mylan.com.