Biosimilars in the United States: Current Status and Future Implications

Biosimilars in the United States: Current Status and Future Implications


Press release

Disclosures: Bresch is CEO of Mylan. Shaw is chairperson of Biocon.
June 17, 2020
3 min read

FDA approves biosimilar insulin glargine


Press release

Disclosures: Bresch is CEO of Mylan. Shaw is chairperson of Biocon.
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The FDA approved a new drug application for a biosimilar to insulin glargine injection in vial and prefilled pens for children and adults with type 1 diabetes and adults with type 2 diabetes, according to an industry press release.

Insulin glargine injection (Semglee, Mylan and Biocon) has an amino acid sequence that is identical to Sanofis insulin glargine (Lantus) and is approved for the same indications. It was approved as a drug product under the 505(b)(2) NDA pathway and is now deemed a biologic under section 351(a), in accordance with the Biologics Price Competition and Innovation Act.

Source: Adobe Stock

This approval is an important milestone, first and foremost for the millions of patients living with diabetes in the U.S. as we seek to expand their access to insulin through more affordable treatment options, Heather Bresch, Mylan CEO, said in the release. Its also another milestone for Mylan as we continue to leverage our scientific, commercial, manufacturing and regulatory expertise to benefit patients, and as we enhance our portfolio with increasingly complex and higher value-chain products, like insulin. Leveraging these capabilities, whether through our internal teams or through strong partnerships like the one weve built with Biocon, strengthens our ability to deliver innovative solutions to patients in the U.S. and around the world.

The approval for biosimilar insulin glargine was based in part on the INSTRIDE studies, which confirmed the pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity of Semglee compared with Lantus in individuals with type 1 and type 2 diabetes.

In the release, Myln noted that favorable judgments on all remaining patent claims asserted by Sanofi against Mylans insulin glargine products have been obtained.

Although Sanofi may seek certain appeals of those judgments, Mylan is confident they will not affect commercialization plans, the company stated in the release.

For INSTRIDE1 and INSTRIDE2, participants were randomly assigned to Mylans proposed insulin glargine, MYL-1501D, or branded insulin glargine, Lantus. INSTRIDE 1 was a 52-week noninferiority study with 558 participants with type 1 diabetes; INSTRIDE 2 was a 24-week study with 560 participants with type 2 diabetes, including insulin-participants. Primary endpoint for both studies was change from baseline in HbA1c after 24 weeks. Secondary endpoints included change from baseline in fasting plasma glucose and insulin dose, as well as safety endpoints. Safety, efficacy and immunogenicity data showed no between-group differences, according to the companies.

The approval of our insulin glargine by the U.S. FDA marks the culmination of a long journey, Kiran Mazumdar Shaw, chairperson of Biocon, said in the release. As an organization committed to making insulin-based therapy increasingly accessible for people with diabetes globally, I am glad this approval will enable us to serve the needs of patients in the U.S. The approval is also an endorsement of our science, scale and expertise to develop highquality, more affordable insulins and shift the access paradigm in favor of patients, taking us closer to realizing our aspiration of reaching one in five insulin-dependent people with diabetes worldwide.


As Healio previously reported in March, the FDA announced the formal transition of insulin and certain other biologic drugs to a new regulatory pathway that will better facilitate the development of biosimilar or interchangeable products. In an agency statement, FDA stated that a small subset of biological products approved under the Federal Food, Drug and Cosmetic Act, such as insulin and human growth hormone, will transition to being officially regulated as biological products, enabling these drugs to serve as the reference product for biosimilar or interchangeable drugs approved through the abbreviated licensure pathway. Prior to this change, the FDA required any follow-on insulins to be approved under the abbreviated new drug pathway; they were not considered to be biosimilar because insulins were approved and regulated as chemical drugs.

Mylan and Biocon Biologics are exclusive partners for a portfolio of biosimilars and insulin analogs, according to the companies. Mylan has exclusive commercialization rights for insulin glargine in the U.S., Canada, Australia, New Zealand, the European Union and European Free Trade Association countries. Biocon Biologics has exclusive rights for Japan and a few emerging markets, and co-exclusive commercialization rights with Mylan in the rest of the world.

Mylan and Biocon Biologics insulin glargine has received regulatory approval in more than 45 countries and is the third product approved by the FDA through the Mylan-Biocon Biologics collaboration.