Summary: The product was originally designated as Myl-1501D. Mylan (now Viatris) submitted an application for approval via the 505(b)(2) NDA pathway in September 2017, because insulin was still regulated under the Food, Drug, and Cosmetics Act of 1962. Subsequently, the FDA elected not to approve the agent in 2018 and 2019. Prior to the approval of Semglee, the FDA took action under section 351(a) in accordance with the Biologics Price Competition and Innovation Act to decree that all insulin copies would be treated as biosimilars effective March 23, 2020. As the FDA approval process for Semglee was already underway, legislative action allowed the approval to move forward under the 505(b)(2) pathway, culminating in an FDA approval June 11, 2020. The product was launched August 31, 2020.
The partners subsequently submitted a 351(k) application for Semglee, seeking interchangeable status with the reference product Lantus. This was granted on July 28, 2021.
A second insulin glargine biosimilar, by Eli Lilly (Rezvoglar, insulin glargine-aglr), was approved on December 17, 2021. This product earned the interchangeable designation on November 16, 2022. As of March 2022, there are now, besides the originator product Lantus, two insulin glargine follow-on agents and two biosimilars.
About the Manufacturer
Viatris was formed when Mylan and UpJohn were combined in 2020. Subsequently on February 28, 2022 Biocon Biologics Limited acquired Viatris’ rights for biosimilar products. Biocon Biologics is a subsidiary of Biocon, Ltd located in India. They manufacture and commercialize complex generics, biosimilars, insulins, and novel biologics. Currently Biocon Biologics has two other FDA approved biologics (Fulphila (pegfigrastim-jmdb) and Ogivri (trastuzumab-dkst) available in the US market.
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.
INSULIN GLARGINE BIOSIMILARS AND FOLLOW-ONS APPROVED BY THE FDA
Manufacturer |
Brand Name and Designation |
Filing Date |
Approval Date |
Eli Lilly |
Basaglar (insulin glargine) |
2014 |
FDA approved December 16, 2015 as a 505(b)2 drug |
Viatris/Biocon |
Semglee (insulin glargine-yfgn) |
2018 |
Approved first as 505(b)2 in June 2020; FDA approved as biosimilar and interchangeable July 28, 2021 |
Eli Lilly |
Rezvoglar (insulin glargine-aglr) |
N/A |
FDA approved December 17, 2021 and as an interchangeable November 16, 2022 |
INSULIN GLARGINE BIOSIMILAR IN DEVELOPMENT
Company Name |
Product Name |
Stage of Development |
Lannett/YiChange HC ChangJiang Pharmaceutical Co., Ltd |
TBD |
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. |
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.
Copyright 2022 by SM Health Communications. All rights reserved.
We are pleased to hear your questions or comments, which should be provided through our contact us page.