FDA tentatively approves second follow-on biologic insulin

The FDA has granted a tentative approval for a second follow-on biologic basal insulin in a pre-filled dosing device, Merck announced in a press release.

The tentative approval of Lusduna Nexvue 100 units/mL, a follow-on biologic to insulin glargine (Lantus, Sanofi), means the drug meets all regulatory standards for follow-on biologics for clinical and nonclinical safety, efficacy and quality, according to the FDA. However, the drug 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 Lusduna Nexvue for up to 30 months, or in the event a court finds in favor of Merck, whichever comes sooner, according to the release.

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

The tentative approval will mark the second follow-on biologic basal insulin to be available in the U.S. Eli Lilly and Boehringer Ingelheim announced that their long-acting human insulin analogue, Basaglar, also a follow-on biologic insulin to Lantus, was available in December.

A follow-on insulin product has an identical amino acid sequence, but is not considered to be a biosimilar due to its FDA regulatory submission pathway via the federal Food, Drug and Cosmetic Act. No insulin glargine products are currently licensed under the Public Health Service Act; insulins are approved and regulated as chemical drugs, so there is no “reference product” for a proposed biosimilar, according to the FDA.

The trade name “Lusduna Nexvue” was granted provisional approval by the FDA and will be used in the U.S. when the product is made available.