biocon

Biocon Biologics, Viatris launch interchangeable insulin biosimilar for US

Viatris Inc. and Biocon Biologics Ltd. today announced the U.S. launch of interchangeable biosimilars SEMGLEE® injection, a branded product, and Insulin Glargine injection, an unbranded product, to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes. Both biosimilar products are available in vial and prefilled pen presentations and are interchangeable for the reference brand, LANTUS® allowing for substitution at the pharmacy counter.

Viatris Head of North America Jose Cotarelo said: “Viatris has a long-standing commitment to improving patient access to sustainable, quality and more affordable healthcare. We are extremely proud to stay true to that promise by bringing to millions of people with diabetes these interchangeable insulin biosimilar treatment options. We are pleased to also offer a broad range of options to help patients, which are intended to maximize access to these important medicines, regardless of financial circumstances, insurance or channel.”

Viatris Inc. is a new kind of healthcare company, empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories. Viatris’ portfolio comprises more than 1,400 approved molecules across a wide range of therapeutic areas, spanning both non-communicable and infectious diseases, including globally recognized brands, complex generic and branded medicines, a growing portfolio of biosimilars and a variety of over-the-counter consumer products.

Shreehas Tambe, dCEO, Biocon Biologics said: “At Biocon Biologics we are committed to expanding access to high-quality, affordable biologics to patients worldwide. The launch of our interchangeable biosimilar insulin glargine in the U.S. 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 U.S. for the benefit of patients and the overall healthcare system.”

SEMGLEE (insulin glargine-yfgn) and Insulin Glargine (insulin glargine-yfgn), co-developed by Viatris and Biocon Biologics, are now available in the U.S. market. The currently marketed non-interchangeable SEMGLEE (insulin glargine) is anticipated to be phased out by the end of the 2021 calendar year.

SEMGLEE (insulin glargine-yfgn) is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. It is not recommended for the treatment of diabetic ketoacidosis. Do not use during episodes of hypoglycemia or if hypersensitive to insulin glargine or it’s excipients. Patients should be instructed to never share the prefilled pen even if the needle is changed. Changes to a patient’s insulin regimen should be done under close medical supervision with increased frequency of blood glucose monitoring as hyper- or hypoglycemia may occur.

Viatris and Biocon Biologics have an exclusive collaboration for the development, manufacturing and commercialization of a broad portfolio of biosimilars and insulin analogs. Viatris has exclusive commercialization rights in the U.S., Canada, Australia, New Zealand, the European Union and European Free Trade Association countries. Biocon Biologics has exclusive commercialization rights for Japan and certain emerging markets. Viatris and Biocon Biologics have co-exclusive commercialization rights in the rest of the world.

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