Second Insulin Biosimilar to Get FDA’s Nod—Eli Lilly’s Rezvoglar™ to Enter the Glargine Market

The complexity of the insulin competition continues to boggle the mind. On December 17, 2021, Eli Lilly received FDA approval of its Rezvoglar (insulin glargine-aglr), a product that is biosimilar to Sanofi’s Lantus®, and marks the second insulin glargine agent approved this year.

Rezvoglar will be available in 3-mL prefilled pens.

Basaglar® was the first follow-on insulin glargine product approved by the FDA (December 2015). This agent is produced by the partnership between Lilly and Boehringer Ingelheim. In 2016, however, insulins were not yet regulated under section 351(k) of the Biologic Competition Price Innovation Act. Yet it was a biosimilar in every other sense of the term, similar pharmacokinetics and pharmacodynamics, producing similar clinical outcomes to Lantus, the originator brand.

Lilly did not issue a press release to announce the new approval. Nor did the company list the product in its most recent investor presentation. The company already produces brand name insulins (e.g., Humalog), as well as an authorized generic form of insulin lispro. So what is the positioning of this agent, especially versus Basaglar? Will Rezvoglar be a de facto authorized biologic to the Basaglar brand, offering further discounts over the older product? Or will the marketing efforts on behalf of Basaglar eventually dwindle so that Rezvoglar can stand alone? The latter is unlikely, as Basaglar has significant uptake by payers at present.

Notably in 2019, the Center for Biosimilars reported that Eli Lilly was considering a “branded biosimilar” approach, as deduced from comments the company made in response to the 2020 transition of insulin to regulation under the Public Health Service Act.

With the holiday season upon us, we were unable to obtain comment from Eli Lilly before publication, regarding launch dates, pricing, or how it will market these two agents.

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