European Commission grants Lilly and Boehringer Ingelheim's insulin glargine product marketing authorisation in Europe
-- First biosimilar insulin to receive regulatory approval in the EU
"The marketing authorisation for this insulin glargine product in
The Alliance's insulin glargine product is a basal insulin with the same amino acid sequence as Lantus® (insulin glargine) and is intended to provide long-lasting blood sugar control between meals and at night.1 Lilly/Boehringer Ingelheim's insulin glargine product will be available in a pre-filled pen and cartridges for a reusable pen.
"Basal insulin is an important mainstay of treatment for people with type 1 and type 2 diabetes, and we're pleased that Lilly/Boehringer Ingelheim's insulin glargine product will provide healthcare professionals and patients with another option to meet their insulin treatment needs, along with significant expertise and support from the
The marketing authorisation for the Alliance's insulin glargine product is based upon a comprehensive clinical data programme, which showed it has similar efficacy and safety compared to the currently marketed insulin glargine product in people with type 1 and type 2 diabetes. The application included results from pharmacokinetic and pharmacodynamic studies, as well as Phase III studies in patients with type 1 and type 2 diabetes.
While 'Abasria' is an approved name in
Lilly/Boehringer Ingelheim's insulin glargine product will be manufactured by Lilly, which has been manufacturing insulin since 1923. This history gives Lilly extensive expertise, insights and knowledge in the insulin space, enabling it to provide high quality medicines to diabetes patients worldwide.
Boehringer Ingelheim and
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim,
Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "
In 2013, Boehringer Ingelheim achieved net sales of about
For more information please visit www.boehringer-ingelheim.com.
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a broad and growing product portfolio and a continued determination to provide real solutions—from medicines to support programs and more—we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com.
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com, @LillyHealth on Twitter and http://newsroom.lilly.com/social-channels.
Lantus® is a registered trademark of Sanofi.
Abasria® is a registered trademark of
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1. Inzucchi SE, Bergenstal RM, et al. Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach. Diabetes Care
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