Mylan and Biocon Biologics India announced the US launch of Semglee (insulin glargine injection) in vial and pre-filled pens, 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 FDA, has an identical amino acid sequence to Sanofi’s Lantus and is approved for the same indications.
“The availability of Semglee provides another quality treatment option for patients living with diabetes in the US,” Thomas Blevins, MD, lead investigator for the INSTRIDE clinical trials, said in a company news release. “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 (noninferior) 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 the medicine, Mylan is offering Semglee at a wholesale acquisition cost (WAC)1 of $147.98 per package of five 3ml pens and $98.65 per 10ml vial, representing the lowest WAC for any long-acting insulin glargine on the market, according to Mylan. 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.
“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,” Mylan CEO Heather Bresch said in the news release. “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.”
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.
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.