Viatris Inc. and Biocon Biologics have announced the launch of interchangeable biosimilars Semglee® (insulin glargine-yfgn) injection, a branded product, and Insulin Glargine (insulin glargine-yfgn) injection, an unbranded product, to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Semglee and Insulin Glargine may now be substituted for the reference product, Lantus® (insulin glargine), at the pharmacy counter without the need for an intervention from the prescriber. Both biosimilar products are long-acting human insulin analogues that have an identical amino acid sequence to Lantus.
Semglee and Insulin Glargine are supplied as 100 Units/mL in 10mL multiple-dose vials and 3mL single-use prefilled pens. The currently marketed noninterchangeable Semglee is expected to be phased out by the end of 2021.
Additionally, Viatris is offering a range of options to assist eligible patients, including a patient assistance program, copay program, voucher, cash-pay programs, and a Medicare Part D Senior Savings Model Insulin Medicare Savings Program.
Shreehas Tambe, dCEO, Biocon Biologics said: “The launch of our interchangeable biosimilar insulin glargine in the US by our partner Viatris, is in line with our aspiration to provide our biosimilar insulins to ‘one in five’ insulin dependent people with diabetes, globally. This is indeed a landmark event and along with the recent formulary listings, we believe it will allow us to improve accessibility, availability and adoption of biosimilars in the US for the benefit of patients and the overall health care system.”
In July 2021, the Food and Drug Administration (FDA) approved Semglee as the first interchangeable biosimilar insulin product to Lantus.
Viatris and Biocon Biologics announce launch of interchangeable Semglee® (insulin glargine-yfgn) injection and Insulin Glargine (insulin glargine-yfgn) injection. News release. Viatris Inc. Accessed November 16, 2021. https://www.prnewswire.com/news-releases/viatris-and-biocon-biologics-announce-launch-of-interchangeable-semglee-insulin-glargine-yfgn-injection-and-insulin-glargine-insulin-glargine-yfgn-injection-301425151.html.