Eli Lilly and Company/Boehringer Ingelheim Corporation Remain Coy on Insulin Glargine's EU, FDA Regulatory Strategies

Published: Feb 08, 2013

High quality global journalism requires investment. Please share this article with others using the link below, do not cut & paste the article. See our Ts&Cs and Copyright Policy for more detail. Email ftsales.support@ft.com to buy additional rights. http://www.ft.com/cms/s/2/83319484-71ff-11e2-886e-00144feab49a.html#ixzz2KKc1kxzw Eli Lilly (NYSE:LLY) and Germany-based Boehringer Ingelheim will potentially have mixed regulatory strategies for LY2963016 (insulin glargine) in diabetes, experts told BioPharm Insight. The drug could be designated as a biosimilar in some territories, noted a Lilly spokesperson. She declined to specify the EU strategy but said some type of New Drug Application (NDA) will be filed in the US. Biosimilars are produced in a manner that renders their effects similar to brand-name biologics and are thus deemed to be acceptable forms of the original biotherapeutics by regulatory agencies. It is unclear whether LY2963016 is a true biosimilar, as the company could have slightly changed the formulation to sidestep patent issues, experts said. The Phase III asset is still, however, the same as glargine structurally, they noted. The drug has the same amino acid sequence as Sanofi’s (EPA:SAN) Lantus (insulin glargine), the spokesperson confirmed, but declined to explain differences between the two. Lilly could submit LY2963016 to US and EU regulatory authorities in 2013, noted the spokesperson.

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