Eli Lilly and Company (LLY - Analyst Report) and partner Boehringer Ingelheim received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the EU for their experimental insulin glargine product, LY2963016.
Eli Lilly and Boehringer Ingelheim are looking to get the product approved for the treatment of type I and II diabetes. The CHMP opinion makes LY2963016 the first biosimilar insulin to be recommended for approval in the EU.
LY2963016, which has been filed under the European Medicines Agency's (EMA) biosimilar pathway, has the same amino acid sequence as Sanofi’s (SNY - Analyst Report) Lantus (insulin glargine). As a result, LY2963016 will be treated as a biosimilar in some territories including Europe. However, it will not be treated as a biosimilar in countries like the U.S.
A final decision from the European Commission should be out in a couple of months. Approval would make LY2963016 the fourth diabetes product under Eli Lilly and Boehringer Ingelheim’s alliance to gain EU approval.
Last month, Jardiance (empagliflozin), a sodium glucose co-transporter 2 (SGLT2) inhibitor, gained approval in the EU for the treatment of type II diabetes. Jardiance is a part of the Eli Lilly- Boehringer Ingelheim alliance and was recently re-submitted for approval in the U.S.
We are pleased with the positive CHMP opinion for LY2963016 and Eli Lilly’s progress with its diabetes pipeline. The biggest near-term challenge for Eli Lilly is replacing the revenues lost due to the Zyprexa, Cymbalta and Evista genericization.
Eli Lilly is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Biogen (BIIB - Analyst Report) and Regeneron Pharmaceuticals (REGN - Analyst Report). Both are Zacks Rank #1 (Strong Buy) stocks.