Mylan & BioCon Announce Regulatory Submission

Mylan N.V. and Biocon Ltd. recently announced that the European Medicines Agency (EMA) has accepted for review Mylan’s Marketing Authorization Application (MAA) for insulin glargine, a long-acting insulin analog used to treat adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood sugar.

Mylan and Biocon, which have co-developed insulin glargine, look forward to offering another insulin treatment option for diabetic patients, who are often facing significant expense to manage their disease. This filing includes analytical, functional, and pre-clinical data, as well as results from the pharmacokinetics (PK) and confirmatory efficacy/safety global clinical trial in type 2 diabetes patients comparing Mylan’s and Biocon’s Insulin glargine with Lantus. The PK study demonstrated PK and PD bioequivalence of Mylan’s and Biocon’s insulin glargine relative to that of the reference drug Lantus.

“The acceptance of our regulatory submission for insulin glargine in Europe is yet another example of the strong progress we continue to make across the exciting portfolio of complex products we have in development, and is another demonstration of the success of our partnership with Biocon. Fifteen percent of the world’s pharmaceutical spend will be on diabetes medicines by 2020, and there is a significant unmet need around the world for more affordable versions of injectable insulin products. We look forward to helping serve this patient population, building on our existing strength in oral diabetic drugs, by bringing this product to the European market and other markets around the world upon approval,” said Mylan President Rajiv Malik.

“The acceptance of the insulin glargine application for review by the EMA is another important milestone in Biocon’s collaboration with Mylan. This is the third filing from our portfolio comprising biosimilar monoclonal antibodies, insulin analogs, and other recombinant proteins to be accepted by EMA in 2016. Importantly, this is the first filing in a developed market that incorporates product validated at our state-of-the-art Malaysia facility and takes us a step closer to our mission of improving access to more affordable insulins globally,” added Dr. Arun Chandavarkar, CEO & Joint MD, Biocon.

Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogs. Glargine is one of the three insulin analogs being co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for insulin glargine in the US, Canada, Australia, New Zealand, the European Union, and European Free Trade Association countries. Biocon has exclusive rights for Japan and a few emerging markets; and co-exclusive commercialization rights with Mylan in the rest of the world.

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 2,700 generic and branded pharmaceuticals, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS worldwide depend. We market our products in more than 165 countries and territories. Our global R&D and manufacturing platform includes more than 50 facilities, and we are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our more than 40,000-strong workforce is dedicated to creating better health for a better world, one person at a time. For more information, visit www.mylan.com.

Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is India’s largest and fully integrated, innovation-led biopharmaceutical company. As an emerging global biopharmaceutical enterprise serving customers in over 100 countries, it is committed to reduce therapy costs of chronic diseases like diabetes, cancer, and autoimmune. Through innovative products and research services it is enabling access to affordable healthcare for patients, partners, and healthcare systems across the globe. It has successfully developed and taken a range of Novel Biologics, Biosimilars, differentiated Small Molecules, and affordable Recombinant Human Insulin and Analogs from Lab to Market. Some of its key brands are INSUGEN (rh-insulin), BASALOG (Glargine), CANMAb (Trastuzumab), BIOMAb-EGFR (Nimotuzumab), and ALZUMAb (Itolizumab), a first-in-class anti-CD6 monoclonal antibody. It has a rich pipeline of Biosimilars and Novel Biologics at various stages of development, including Insulin Tregopil, a high potential oral insulin analog