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European committee recommends approval of insulin biosimilar
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The European Committee for Medicinal Products for Human Use, or CHMP, granted a positive opinion for the recommendation of LY2963016, a new insulin glargine product considered a biosimilar in Europe.
“The CHMP’s recommendation brings us a step closer to providing an important new option for the millions of patients in the EU who need basal insulin to help manage their diabetes,” Enrique Conterno, president of Lilly Diabetes, said.
This decision is based upon previously reported studies comparing this new drug to Lantus (insulin glargine, Sanofi Aventis), as it is derived from the same amino acid sequence, and other studies, according to the release.
Though this is considered a “first-ever biosimilar insulin to receive a positive CHMP recommendation,” Conterno said, it will be treated as an entirely new drug in the United States where it is also undergoing FDA review.
The company estimated that the European Commission’s final decision would be delivered in approximately 2 months, according to the release.
For more information: CHMP recommends Lilly and Boehringer Ingelheim’s new insulin glargine product for approval in the European Union