Eli Lilly and Company
) and partner Boehringer Ingelheim gained tentative FDA approval
for their diabetes treatment, Basaglar (insulin glargine
injection). The companies are looking to get the drug approved for
improving glycemic control in adults with type II diabetes and in
combination with mealtime insulin in adults and pediatric patients
with type I diabetes.
Basaglar, which has been filed under the FDA's 505(b)(2)
regulatory pathway, has the same amino acid sequence as Sanofi's (
) Lantus (insulin glargine). Sanofi has filed a patent infringement
lawsuit against Eli Lilly and Boehringer. As a result, the FDA
cannot grant final approval until the end of the 30-month stay
period in mid-2016 or a favorable court ruling, whichever occurs
Although Basaglar has the same amino acid sequence as Lantus, it
will not be treated as a biosimilar in the U.S. However, in other
markets like Europe, it will be treated as a biosimilar. We note
that earlier this year in June, Eli Lilly-Boehringer's insulin
glargine product received a positive opinion from the Committee for
Medicinal Products for Human Use (CHMP) in the EU. Approval should
We are encouraged by Eli Lilly's progress with its diabetes
pipeline. Earlier this month, the FDA approved another diabetes
drug developed under the Eli Lilly- Boehringer collaboration.
Jardiance (empagliflozin), a sodium glucose co-transporter 2
(SGLT2) inhibitor, gained approval in the U.S. for the treatment of
type II diabetes. It is already approved in the EU.
Eli Lilly is a Zacks Rank #3 (Hold) stock. Some better-ranked
stocks in the pharmaceutical sector include Allergan (
) and AstraZeneca plc (
). While Allergan is a Zacks Rank #1 (Strong Buy) stock,
AstraZeneca is a Zacks Rank #2 (Buy) stock.
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