The drug, an injection known also as insulin glargine, is a
long-acting, man-made version of human insulin. It is the first
insulin product approved through a shortened review process based on
its similarity to an existing drug.
The FDA determined that Basaglar was sufficiently similar to Lantus
to justify approval based on the safety and effectiveness of Lantus
as well as certain Basaglar-specific data.
In September Lilly entered a settlement agreement to resolve patent
litigation with Sanofi over Basaglar, allowing Lilly and its
partner, Boehringer Ingelheim, to launch Basaglar in the United
States in December 2016. The FDA tentatively approved Basaglar in
Greg Kueterman, a Lilly spokesman, said the company has not set a
price for the drug, though he noted it will be cheaper than Lantus.
Lantus generated sales in 2014 of more than $8 billion. Rivals have
been lining up to take advantage of the drug's patent expiry to
launch cheaper versions. Basaglar was approved in Europe as a
biosimilar last year. The FDA is calling the product a "follow-on"
biologic rather than a biosimilar.
[to top of second column]
There are some 30 million people with diabetes in the United States.
(Reporting by Toni Clarke in Washington; Editing by Matthew Lewis
and David Gregorio)
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