Biocon Biologics India, a fully integrated biosimilars company and a subsidiary of Biocon Ltd, and Mylan N.V. on Monday announced the US launch of Semglee (insulin glargine injection).
The drug is being made available 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 got final approval from the US Food and Drug Administration (FDA), has an identical amino acid sequence to Sanofi’s Lantus and is approved for the same indications.
Thomas Blevins, M.D., lead investigator for the INSTRIDE clinical trials, said: “The availability of Semglee provides another quality treatment option for patients living with diabetes in the US. 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 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.
Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, said: “The commercialisation of our insulin glargine in the US 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 US. 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 US launch of Semglee takes us closer to realising our aspiration of reaching ‘one in five’ insulin dependent people with diabetes worldwide.”