Biocon Gains EU Authorization for Insulin Aspart Biosimilar
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.
Biosimilars Regulatory Roundup for September 2023—Podcast Edition
October 1st 2023On this episode, we discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.
BioRationality: FDA Launches a New Opportunity to Remove Redundant Trials of Biosimilars
November 6th 2023The FDA introduced a plan to improve clinical trials, including a provision to possibly eliminate clinical efficacy testing for biologic products, which evidence has suggested may not be necessary, according to Sarfaraz K. Niazi, PhD.
