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In a Race for a New and Cheaper Insulin Glargine, Legal Troubles May Delay New Products From Coming to Market

Do you ever wonder why there aren’t cheaper “generic” insulin products available? This may soon change as the patents for branded insulin begin to expire. In fact, the patents for Sanofi’s top-selling Lantus (basal insulin glargine) are set to expire in the US in 2015, and other companies are racing to produce new “generic” insulins that could provide more choices for patients and importantly, push down the prices. The term “generic” traditionally applies to small molecules that are chemically and structurally equivalent to the original drug. Biosimilars created for products like insulin are biologically created products that tend to be more complex and sensitive. Thus it is difficult to completely prove that a biosimilar drug is identical to the original like a true “generic” drug. To learn more about “generic” insulin products and how they are defined, please read on in diaTribe #26.

The race has already started. On December 20, Eli Lilly and Boehringer Ingelheim announced the submission of a new basal insulin glargine to the FDA. The compound, called LY2963016, is under regulatory review in the US, Europe, and Japan. In January, we learned that Sanofi has filed a lawsuit against Lilly alleging patent violations of the original top-selling Lantus (insulin glargine) – the lawsuit could delay the FDA’s decision on drug approval for up to 30 months, which would push back potential approval to 2016. This is a bit of a surprise and we’re working on “unpacking” this to better understand the moves on each side. 

Other companies are getting into the game as well. Merck and Samsung Bioepsis announced a partnership in February to develop a “generic” insulin glargine, and phase 3 testing of the drug candidate will begin “soon” for its candidate MK-1293. India-based Biocon also has its own “generic” insulin glargine product, which is already approved in more than ten countries around the world and is beginning a phase 3 trial this year. Despite the uncertainty around legal matters, there is certainly a lot of interest in bringing a cheaper version of insulin glargine to market. –NL