PITTSBURGH—  Mylan N.V.  and Biocon Biologics India Ltd., a subsidiary of Biocon Ltd., announced on Monday the U.S. launch of Semglee (insulin glargine injection) in vial and pre-filled pen presentations, approved to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes. It is not recommended for the treatment of diabetic ketoacidosis. Semglee, which received final approval from the U.S. Food and Drug Administration (FDA), has an identical amino acid sequence to Sanofi’s Lantus and is approved for the same indications.

Dr. Thomas Blevins, lead investigator for the INSTRIDE clinical trials, said: “The availability of Semglee provides another quality treatment option for patients living with diabetes in the U.S. We rigorously compared Semglee (insulin glargine injection) to the reference insulin glargine in participants with Type 1 and 2 diabetes and found that Semglee yielded similar (non-inferior) glycemic results in both groups. The safety, including immunogenicity, was similar too. As a result, this insulin was approved by the FDA for the same indications as its reference product Lantus, thus expanding access for millions of people within this important patient community.”

To encourage broad patient access to this important medicine, Mylan is offering Semglee at a wholesale acquisition cost (WAC)¹ of $147.98 per package of five (5) 3ml pens and $98.65 per 10ml vial, representing the lowest WAC for any long-acting insulin glargine on the market. The list price of Semglee pen is equivalent to the Lantus launch price in 2007, and the Semglee vial is listed at Lantus’s 2010 pricing. Eligible patients may also qualify for patient assistance and/or a co-pay card, similar to other medications in this class. Additionally, Mylan has submitted to FDA all necessary documentation to request approval of Semglee as a biosimilar to Lantus under the 351(k) pathway and remains confident in seeking an interchangeability designation.

Mylan CEO Heather Bresch said: “We are proud to be the first company, following the reference product, to receive FDA approval on and launch both the vial and pen presentations of an insulin glargine treatment with an identical amino acid sequence to Sanofi’s Lantus®. Even more importantly, we are proud to make Semglee available to the more than 30 million Americans living with diabetes in the U.S.², providing more treatment options and increasing access. While providing our product at the most competitive list price on the market is an important step toward ensuring that those who need insulin are able to access and afford it, we also know that there is still work to be done to ensure this access and affordability reaches patients at the pharmacy counter. We remain committed to work across the healthcare system to improve outcomes for all.”

Mylan president Rajiv Malik added: “Bringing to market both the vial and pen presentations of Semglee, the first for any company following the reference product, required years of investment and commitment, and represents another important example of the power of the unique platform we’ve built along with our partner Biocon Biologics in terms of our research and development, regulatory, legal and commercial expertise. Today’s launch also furthers our continued efforts to serve patients through the availability of a full portfolio of short- and long-acting insulins, which also includes our insulin aspart that we expect to launch next year. Our near-term strategy to ensure the availability of Semglee will require a strategic and targeted phased launch approach. Over the long term, we expect this addition to our portfolio to play an increasingly important role within our global biosimilars and insulin analog franchise as well as our efforts to advance access to complex medicines.”

Kiran Mazumdar-Shaw, executive chairperson, Biocon added: “The commercialization of our insulin glargine in the U.S. represents another milestone achievement for Biocon in making insulin-based therapy increasingly accessible for people with diabetes globally. We are confident that along with our long-standing partner Mylan, we will be able to address the needs of millions of patients living with diabetes in the U.S.  Leveraging our science and global scale manufacturing expertise, we have been expanding affordable access to biosimilar insulins to patients in Japan, Australia, Europe, India and key emerging markets. The U.S. launch of Semglee takes us closer to realizing our aspiration of reaching ‘one in five’ insulin dependent people with diabetes worldwide.”

Dr. Christiane Hamacher, CEO, Biocon Biologics said: “It is indeed a proud moment for Biocon Biologics to make Semglee (insulin glargine injection) available to patients in the U.S. Our unwavering focus on developing and manufacturing global quality insulins enables us to address the growing needs of diabetes patients and the healthcare systems. We stay committed to expand affordable access to life-saving global quality biosimilars and insulin analogs and generating savings for the U.S. healthcare system. We believe the U.S. market represents a great opportunity for us and expect Semglee to contribute significantly to our goal of impacting 5 million patients’ lives and achieving $1 billion revenue by end of FY22.”

The approval for Semglee was based on a comprehensive analytical, preclinical and clinical program (including the INSTRIDE studies) which confirmed the PK/PD, efficacy, safety profile and immunogenicity of Semglee as compared to Lantus in patients with type 1 and type 2 diabetes.

Today’s launch follows favorable judgments on all remaining patent claims asserted by Sanofi against Mylan’s insulin glargine products. Although Sanofi may seek certain appeals of those judgments, Mylan is confident they will not affect commercialization.

Sanofi’s total IQVIA sales for the 12 months ending June 30, 2020 were approximately $1.64 billion for Lantus 100 Units/mL Vial and approximately $4.36 billion for Lantus SoloSTAR Pen.

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