Product Profile:

Insulin glargine-agir (Rezvoglar)

Drug Category: insulin, long-acting

Target Indications: To improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus (T1D) and in adults with type 2 diabetes mellitus (T2D).

Manufactured and marketed by Eli Lilly

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).

About the Manufacturer

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.

News, Commentary, and Intelligence

Competitor Products and Manufacturer Analysis

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.



Brand Name and Designation

Filing Date

Approval Date

Eli Lilly

Basaglar (insulin glargine)


FDA approved December 16, 2015 as a 505(b)2 drug


Semglee (insulin glargine-yfgn)


Approved first as 505(b)2 in June 2020; FDA approved as biosimilar and interchangeable July 28, 2021

Eli Lilly

Rezvoglar (insulin glargine-aglr)

December 18, 2020

FDA approved December 17, 2021 and as an interchangeable November 16, 2022


Company Name

Product Name

Stage of Development

Lannett/YiChange HC ChangJiang Pharmaceutical Co., Ltd


An Investigational New Drug application was completed in January 2022. The pivotal clinical trial was scheduled to begin by March 2022 (anticipated completion by early 2023). Possible BLA in late 2023.

Lilly’s Rezvoglar Joins the Ranks of the Interchangeable Insulins

(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.

Insulin Wars: Biosimilar Sustainability May Soon Be an Issue With Civica’s Announcement

(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.

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

(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.

Basaglar® Competition Had a Strong Effect on Insulin Glargine Net Prices

(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.

Insulin Follow-ons, Authorized Generics, Biosimilars, and Interchangeables: A Stew of Competitive Ingredients

(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.

New Entrant into Insulin Market Wants to File as Biosimilar in 2022

(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.

Mylan/Biocon’s Insulin Drug Saga Ends With an Approval

(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.

Transition Day for Insulins, Other Products

(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.

The Appropriations Bill Alters Insulin Biosimilar Rules

(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.

Insulin Transitions: A Dead Zone in the Gap Year, and Other Considerations

(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.

Integrating insulin biosimilars into practice

The impact of type 2 diabetes on families and caregivers

Clinical Trials of Rezvoglar

Eli Lilly submitted its 351(k) application on Rezvoglar, based on its existing Basaglar follow-on insulin glargine 505(b)2-approved product. The FDA requested that Lilly submit recently manufactured batches of Basaglar to support the biosimilar approval, as the lots used to approve Basaglar were from 2012-2014. The FDA’s approval of Rezvoglar was then predicated on pharmacologic and pharmacokinetic data only.  However, Lilly did perform a clinical study comparing clinical outcomes of this agent with those of Lantus.

A study of LY2963016 compared to Lantus in adult Chinese participants with type 2 diabetes mellitus

A randomized, open-label trial comprising 536 Chinese patients with type 2 diabetes mellitus was conducted to compare outcomes obtained with Lilly’s insulin glargine agent(N = 359) and the reference product Lantus (N = 177). None of the patients had used insulin in the past. Each therapy was administered subcutaneously for 24 weeks. Doses were titrated to maintain a fasting blood glucose level of ≤100 mg/dL while avoiding hypoglycemia. Oral antihyperglycemic medications were continued during the course of the study.

The mean change in the primary endpoint (A1c level) at week 24 was -1.27 percentage points in the study group and -0.123 percentage points in the Lantus group (P =.54).  The secondary outcome, percentage of patients with an HbA1c level < 7% at week 24 was also similar (43.7% in the study group vs. 44.9% in the Lantus group). A nonsignificant difference was found in the percent of patients attaining an A1c level of ≤ 6.5% at week 24 (23.4% vs. 16.5%; P = .098).

The safety profiles of both the study medication and Lantus was very similar, and this phase 3 study proved that the biosimilar candidate LY2963016 was noninferior to Lantus in terms of efficacy and safety.

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