Bengaluru (Karnataka) [India], Aug 31 (ANI): Biocon Biologics and Mylan on Monday announced the US launch of Semglee™ (insulin glargine injection) in vial and pre-filled pen presentations, approved to help control high blood sugar in adult and paediatric 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 US Food and Drug Administration (FDA), has an identical amino acid sequence to Sanofi's Lantus' and is approved for the same indications, a press release issued by Biocon and Mylan said.
Dr Thomas Blevins, MD and 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 (WAC) of USD 147.98 per package of five 3 mI pens and USD 98.65 per 10 mI vial, representing the lowest WAC for any long-acting insulin glargine in the market.
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," she added.
Mylan president Rajiv Malik said: "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 the 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," he added.
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. (ANI)