The EU recommended approval a biosimilar of Lantus developed by Eli Lilly and Boehringer Ingelheim.
The two companies announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended use of their new insulin glargine product, Abasria, for the treatment of type 1 and type 2 diabetes.
The approval, the first for an insulin biosimilar in the EU, not only creates the leading edge of a wedge between Sanofi ($SNY) and its mega blockbuster’s sales, it is an approval that should help propel the acceptance of biosimilars in the EU where uptake on biosimilars so far has been slow. Lilly said Abasria is not considered a biosimilar in the U.S.
But Sanofi has not been just holding its breath awaiting the onslaught. Sanofi is working on a new, long-acting Lantus successor known as U300, for which the the company expects FDA approval in 2015. Holding off the Lilly copy until 2016 gives it time to get doctors to make the switch.
From editors@fiercepharma.com
The EMA authorisation of Abasria – insulin glargin
http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002835/WC500169353.pdf
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