The FDA has granted Eli Lilly “tentative” approval for a
diabetes medication akin to Sanofi’s Lantus.
The drug, to be marketed as Basaglar, is a long-lasting insulin
injection that helps to control blood-sugar levels and is essentially a knockoff
of the Sanofi version.
The new medication, however, won’t reach shelves for at
least 30 months as Sanofi has filed a suit claiming patent infringement. The drug could hit the market earlier if the
court rules in favor of Eli Lilly but is in a holding pattern until then. Lantus is scheduled to come off of patent February
of next year. This news comes months
after Merck divulged plans to develop its own knockoff of the diabetes medication.
Basaglar has the same amino acid sequence as Sanofi’s drug
but for technical reasons is not considered a biosimilar—although for all
intents and purposes, it is one. By
European standards, the drug does actually fall under the biosimilar
classification and goes by the name Abasria.
Said Christophe Arbet-Engels, Vice President,
Metabolic-clinical Development and Medical Affairs, Boehringer Ingelheim
Pharmaceuticals, Inc., "Because of the combined diabetes, development and
commercialization experience of Lilly and Boehringer Ingelheim, we are
confident that Basaglar, upon final approval, will become a valuable treatment
choice for people who need a basal insulin to manage their type 1 or type 2
diabetes."
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