Rezvoglar

Summary: Eli Lilly filed its 351(k) application for this insulin glargine biosimilar on March 18, 2020 and received US FDA approval to market Rezvoglar on December 17, 2021; in November 2022, Originally designated LY2963016, Rezvoglar is simply a representation of more recent manufacturing lots of Lilly’s previously approved Basaglar follow-on glargine product, which the company wanted to be designated as a biosimilar, potentially for subsequent licensure as an interchangeable glargine biosimilar (to Sanofi’s reference product Lantus), making it the second interchangeable glargine product (after Semglee).  This product is not yet marketed; Lilly also owns the Basaglar brand, for which it earned over $750 million in 2021. By December 2022, Lilly has not disclosed marketing plans for Rezvoglar. It is of note that Lilly is also investigating a weekly injectable glargine formulation (LY3209590).

Eli Lilly and Company, based in Indianapolis, Indiana, was founded nearly 150 years ago. Lilly has been a dominant player in the diabetes arena, with marketed products that include Humalog and Humulin, Trulicity, Jardiance (as part of a partnership with Boehringer Ingelheim), Basaglar, and Mounjaro, and now the biosimilar Rezvoglar, which is not yet marketed. Lilly earned $28 billion in 2021, and is also active in the immunology, oncology, and pain management space.

Semglee was the first insulin glargine designated biosimilar and interchangeable to the reference product Lantus. Two other insulin glargine follow-on agents were approved in the US (Basaglar by Eli Lilly and Lusduna by Samsung Bioepis and Merck, the latter was no longer available in the US as of 2018). This market is also complicated by the availability of nonbranded “authorized” versions of reference and biosimilar agents.

INSULIN GLARGINE BIOSIMILARS AND FOLLOW-ONS APPROVED BY THE FDA

INSULIN GLARGINE BIOSIMILAR IN DEVELOPMENT

(November 18,, 2022) On November 16, the Food and Drug Administration (FDA) granted its second interchangeable designation to an insulin glargine product, Rezvoglar^®, manufactured by Eli Lilly. Rezvoglar was first approved as a biosimilar in December 2021.

(March 4,, 2022) The announcement on March 4 that Civica, the private-public partnership among 25 health systems, plans, and foundations, will be producing low-cost insulin in the near future may shake biosimilar insulin competition to its foundations.

(December 24, 2021) 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.

(October 21, 2021) According to a study published in JAMA Internal Medicine this month, the approval and launch of the follow-on insulin glargine product Basaglar turned the tide on rising costs for this long-acting insulin.

(October 13, 2021) With the Food and Drug Administration’s (FDA’s) recent approval of the first interchangeable insulin, Viatris and Biocon’s Semglee^®, some questions may begin to be answered with respect to payer coverage, automatic substitution, and their potential for success in the marketplace. However, unlike the other biologic drug categories, there are additional levels of complexity among the insulins that may affect future competition.

(June 15, 2020) Lannett, a maker of generic pharmaceutical products, disclosed that it has been in talks with the Food and Drug Administration (FDA) about bringing a biosimilar version of insulin glargine into clinical trials.

(June 12, 2020) Although Mylan and partner Biocon did not beat the March 22, 2020 deadline for the transition of new insulins to biosimilar status, they were able to secure a 505(b)2 FDA approval for their insulin glargine follow-on agent.

(March 24, 2020) On Monday, March 23, biologic products formerly evaluated for approval under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) are now approvable only under section 351 of the Public Health Service Act (PHS Act). That means many categories of drugs will now be considered eligible for biosimilar competition.

(December 20, 2019) Closing out the week before the holidays, the House and Senate’s Appropriations Bill specified two significant passages that affect the March 22, 2020 transition date for insulins being approved under the 351(k) pathway. Here’s a summary of these two points.

(September 27, 2019) In this two-part conversation with one of the real go-to experts in the biosimilar field and US regulatory process, we talk with Dr. Gillian Woollett about the upcoming transition for insulins and other pharmaceuticals in March 2020, when they become regulated as 351(k) biosimilars.

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