Mylan and Biocon Receive Approvals from the European Commission and TGA Australia for Semglee™, Biosimilar Insulin Glargine

HERTFORDSHIRE, UK and PITTSBURGH, PA, USA and BENGALURU, India I March 27, 2018 I Mylan N.V. (NASDAQ: MYL), one of the world's leading pharmaceutical companies, and Biocon Ltd. (BSE code: 532523, NSE: BIOCON), Asia's premier biopharmaceutical company, today announced that their co-developed biosimilar insulin glargine Semglee™ has received marketing authorization approval from the European Commission (EC) following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency. Semglee™ 100 units/mL 3 mL prefilled disposable pen for people with diabetes, is the first biosimilar from Biocon and Mylan's joint portfolio to be approved in Europe.

Additionally, the Therapeutic Goods Administration (TGA), Australia has also approved biosimilar insulin glargine Semglee™ 100 IU/mL 3 mL prefilled pen for the people with diabetes in Australia.

Mylan President Rajiv Malik said, "We are excited to be able to bring Mylan and Biocon's biosimilar insulin glargine to Europe and Australia where millions of people are currently living with diabetes, and we are committed to continuing to bring high quality, more affordable biosimilar products to markets around the world. The investments that we have made to develop and manufacture a leading portfolio of complex products, including Semglee™, is one way that we are delivering on our commitment to expand access to high quality medicine."

Dr. Arun Chandavarkar, CEO and Joint Managing Director, Biocon, said, "The approval of  Mylan and Biocon's biosimilar insulin glargine by the European Commission and TGA Australia are important milestones in our collaboration. It furthers our mission to provide a high quality, affordable insulin analog for people with diabetes globally. As a credible, global insulins player, we are committed to address the growing healthcare challenges associated with diabetes and have made significant investments in R&D and manufacturing to build scale and make our affordable insulins portfolio available in many markets."

The EC approval of Semglee™ applies to all 28 European Union (EU) member states and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.

Diabetes is the fastest growing chronic condition in the world and the prevalence of this disease is increasing among all ages. In Europe the number of diabetics are expected to grow to 38 million by 2030**, while in Australia it currently affects nearly two million* people.

Mylan plans to launch Semglee™ in Australia later this year and expects to begin launching the product across various markets in Europe in the second half of 2018. 

In addition to these approvals, marketing applications for Semglee™ have been submitted in Canada and the U.S., and are planned for key Emerging Markets.

Source: *Diabetes Australia **EU website

About the Mylan and Biocon Collaboration
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 U.S., 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.

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. And we offer a leading portfolio of complex products, which includes 16 biosimilar and insulin analog products on the market or in development worldwide. These include 8 of the top 10 biologics in areas of oncology, immunology, endocrinology and ophthalmology.

Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.

About Biocon
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 120 countries, it is committed to reduce therapy costs of chronic diseases like diabetes, cancer and autoimmune. Biocon is among the Top 3 biosimilar insulins player globally in terms of volume share and has been committed to affordable diabetes management through its portfolio of recombinant human insulin and insulin analogs in India and several global markets. 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), KRABEVA ® ( Bevacizumab) and ALZUMAb™ (Itolizumab), a 'first in class' anti-CD6 monoclonal antibody. The Company has a rich pipeline of Biosimilars and Novel Biologics at various stages of development including Insulin Tregopil, a high potential oral insulin. For more information log on www.biocon.com and follow-us on twitter: @bioconlimited

SOURCE: Mylan

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