First Biosimilar Insulin, Glargine, Approved in EU

Disclosures

September 10, 2014

Lilly and Boehringer Ingelheim's biosimilar insulin glargine product has been approved in the European Union, the 2 companies announced today. The product is a basal insulin, an important mainstay of treatment for people with type 1 and type 2 diabetes.

This is the first biosimilar insulin to receive regulatory approval in Europe, through the European Medicines Agency's (EMA's) biosimilar pathway, and is indicated to treat diabetes in adults, adolescents, and children aged 2 years and above. This follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) in June.

The product has the same amino acid sequence as the currently marketed insulin glargine (Lantus, Sanofi) and is intended to provide long-lasting blood glucose control between meals and at night. Lantus currently generates almost $8 billion in sales for the French company.

Lilly/Boehringer Ingelheim's insulin glargine biosimilar product will be available in a prefilled pen and cartridges for a reusable pen. While Abasria is approved as a brand name in Europe, the companies say they intend to come up with a global trade name, which will be announced at a later date.

In the United States, the Food and Drug Administration granted tentative approval for the product last month, with the provisional trade name Basaglar. This means that the product meets all of the regulatory requirements, said Lilly and Boehringer Ingelheim, but the approval is subject to an automatic "stay" of up to 30 months as a result of litigation filed by Sanofi claiming patent infringement.

Also, the Lilly/Boehringer Ingelheim product is not considered a "biosimilar" in the United States.

The whole issue of biosimilars is controversial, and it's still not clear how this issue will play out in the insulin market. A biosimilar is defined as a copy of a biological molecule that is already approved — for instance, a recombinant insulin such as glargine.

The EMA developed specific guidelines regarding biosimilars in 2004, which were updated in 2014 especially for insulin biosimilars.

But the preparation of biosimilars is much more complex compared with conventional generics, one expert told the American Diabetes Association meeting in June.

Manufacture is performed in living organisms, and there can be an "extremely sensitive" response to alterations in the production process, said Marcus Hompesch, MD, CEO of the Profil Institute for Clinical Research in San Diego, California, as reported by Medscape Medical News.

Thus, a biosimilar can never be the original's identical copy, and it remains to be seen if biosimilars can contribute to better patient care, he noted.

Another Option for Doctors and Patients

For its part, the Lilly/Boehringer Ingelheim alliance says their insulin glargine product will provide healthcare professionals and patients with "another option" to meet their insulin treatment needs.

The companies note that the marketing authorization is based on a comprehensive clinical data program, including results from pharmacokinetic and pharmacodynamic studies, as well as phase 3 studies in patients with type 1 and type 2 diabetes.

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