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Nov 15, 2018

Mylan and Biocon announce the launch of Semglee®▼, an Insulin Glargine biosimilar, in the UK

HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India – 14 November 2018 -- Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced the UK launch of Semglee® (Insulin Glargine solution for injection in pre-filled pen) 100 units/mL, an approved biosimilar of reference insulin glargine.

Semglee®, insulin glargine, is a once-a-day, long-acting basal insulin and is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.

Diabetes is a growing healthcare problem worldwide. In Europe alone, 66 million people have diabetes, which is predicted to rise to 81 million by 20451 . In the UK, 3.7 million people have been diagnosed with diabetes and a further 12.3 million people are at increased risk of type 2 diabetes2. If nothing changes, more than five million people will have diabetes in the UK by 20253.

With an estimated one in 17 people in the UK with diabetes4 , the prevalence is a huge growing concern for the NHS, which currently spends approx. 10% of its entire budget on diabetes management5 . This has led to a growing need for more affordable treatment options for healthcare providers (HCPs) and their patients, to improve access to a broader range of treatment options for diabetes sufferers, which is critical to managing this growing healthcare challenge.

Mylan UK Country Manager, Jean-Yves Brault commented: “Insulin glargine biosimilars play a key role in the challenges faced by the NHS and offer a better value option by being able to deliver increased affordability compared with the originator insulin glargine while still offering comparable safety, efficacy and tolerability. It shows our continued commitment to positively impact the health, and lives, of patients throughout the UK, who suffer from chronic conditions such as diabetes.

We are delighted to be able to bring to market Semglee, with our partner Biocon, and this launch strengthens and supports our global diabetes and metabolism portfolio of 400 products.”

Paul V Thomas, Chief Commercial Officer, Biocon Biologics said: "The UK launch of Semglee, a biosimilar insulin glargine co-developed by Biocon and Mylan, is a reflection of our long-standing commitment to increasing insulin access for diabetes patients through the development of high quality biosimilars.”

Mylan partnered with Biocon, the developer and supplier of its European insulin glargine injections and has exclusive distribution and supply rights for the product across all 28 European Union (EU) member states and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.

Mylan has a portfolio of 20 biosimilar and insulin analog products – one of the industry’s largest and most diverse portfolios – and deep experience with more than 60 marketing authorizations for biosimilar products worldwide.

About the Mylan and Biocon Partnership

Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. Semglee is one of 11 biologic and insulin products 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. 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 www.investor.mylan.com

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. It has developed and taken differentiated Small Molecules, Novel Biologics and a range of Biosimilars (Monoclonal Antibodies, Pegfilgrastim, rh-Insulin and Insulin Glargine) from 'Lab to Market' in India, key emerging and developed markets. It has a large portfolio of biosimilars under clinical development with three of these approved in developed markets of US, EU, Japan and Australia. Its Novel pipeline includes promising assets like Insulin Tregopil, anti-CD6 antibody and a fusion protein for immuno-oncology. Some of its key brands are INSUGEN® (rh-insulin), Basalog One® (prefilled Glargine pen), CANMAb™ (Trastuzumab), KRABEVA® (Bevacizumab), BIOMAb-EGFR® (Nimotuzumab) and ALZUMAb™ (Itolizumab). Follow-us on Twitter: @bioconlimited, www.biocon.com

How to report an adverse event
▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare providers are asked to report any suspected adverse reactions. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. In order to support effective tracking and traceability of biologics including biosimilars, it is recommended that the brand name and batch number are recorded and used when reporting adverse events.

1International Diabetes Federation (IDF). IDF Diabetes Atlas, 7th edn. Brussels, Belgium: International Diabetes Federation, 2015. Available at: http://www.diabetesatlas.org
2 Diabetes UK, Facts and Figures. Available at: https://www.diabetes.org.uk
3 Diabetes UK, Facts and Figures. Available at: https://www.diabetes.org.uk
4 Diabetes: Facts and stats, https://www.diabetes.org.uk/resources-s3/2017-11/diabetes-key-stats-guidelines-april2014.pdf
5 Cost of diabetes report https://www.diabetes.co.uk/cost-of-diabetes.html