- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
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.
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.
