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CHMP recommends EMA approval of biosimilar insulin

  • Europe's Committee for Medicinal Products for Human Use (CHMP) recommends that the European Medicines Agency (EMA) approve Eli Lilly (LLY) and Beohringer Ingelheim's investigational compound LY2963016, a new insulin glargine product, for the treatment of type 1 and type 2 diabetes. It is the first biosimilar insulin recommended for E.U. approval. It has the same amino acid sequence as Sanofi's Lantus (insulin glargine).
  • The European Commission's final decision is expected in ~2 months.
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