The Bengaluru, India, company said the fast-acting biosimilar will improve affordability of insulin in Europe, which also faces rising prices and access problems.
The European Commission (EC) has approved an insulin aspart biosimilar (Kixelle) for marketing. The product is a fast-acting insulin developed by Biocon Biologics, of Bengaluru, India.
Kixelle is indicated for the treatment of diabetes in adults, adolescents, and children at least 1 year of age. It was approved as a 100 units/mL solution for injection and will be available in vials and prefilled pens.
"The approval will enable affordable access to a rapid-acting insulin analog for people with diabetes in the EU [European Union], where our biosimilar insulin glargine, a long-acting insulin analog, is already addressing patients’ needs for an affordable quality treatment option,” Biocon said in a statement. The insulin glargine product, a longer-acting insulin, is Semglee (referencing Lantus), which is also available in the United States via a Biocon partnership with Viatris.
Biocon said the authorization allows distribution of the product in all EU member states and Iceland, Liechtenstein, and Norway, which are in the European Economic Area.
The Kixelle EC approval decision arrived as scheduled for Biocon and its partner in the project, Viatris, which anticipated an early 2021 authorization following a positive recommendation from the European Medicines Agency Committee for Medicinal Products for Human Use.
Biorationality: Advice for the FDA, Biosimilar Developers on Reducing the Cost of Clinical Testing
May 15th 2023Although the FDA has consistently edited its testing guidelines for biosimilar developers over the years, clinical testing is still very expensive and time-consuming. Sarfaraz K. Niazi, PhD, offers the FDA and companies a plan of action for reducing clinical testing expenses for biosimilar products.
Biosimilars Regulatory Roundup for November 2022—Podcast Edition
December 4th 2022On this episode of Not So Different, we recap some of the big regulatory news to come out of November, including some progress for insulin biosimilars, the European approval of another ranibizumab biosimilar, and the congressional introduction of a US Senate bill that is seeking to nix switching study requirements for interchangeability.
Samsung Bioepis Report Correlates Biosimilar Pricing Changes With Market Adoption
May 10th 2023In the first edition of Samsung Bioepis’ Biosimilar Market Report, the company outlined the current state of the US biosimilars market and how increasing adoption has had an impact on pricing changes for biosimilars and their reference products.
2 Clarke Drive
Cranbury, NJ 08512