FDA tentatively approves Merck biosimilar pending patent suit settlement

The US Food and Drug Administration (FDA) has tentatively approved a Merck biosimilar, pending resolution of a patent dispute.

Yesterday, July 20, Merck announced that its diabetes treatment Lusduna Nexvue (an insulin glargine injection) was tentatively approved.

The injection is being developed by Merck with funding from Samsung Bioepis.

Although the treatment has met regulatory standards, it is subject to an automatic stay due to a lawsuit from Sanofi claiming patent infringement.

Under the Hatch-Waxman Act, the initiation of Sanofi’s lawsuit in September 2016 automatically invoked a stay on final FDA approval of Merck’s treatment for a period of up to 30 months, or in the event a court finds in favour of Merck, whichever comes sooner.

Sanofi sued Merck at the US District Court for the District of Delaware, alleging patent infringement of its drug Lantus (an insulin glargine injection).

“The tentative approval of Lusduna Nexvue is an important milestone, bringing us closer to offering this medicine to patients,” said Sam Engel, associate vice president of Merck clinical research, diabetes, endocrinology and women’s health.

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