- 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.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
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.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
Revolutionizing Biopharmaceuticals: The EU's Biosimilar Success and Remaining Challenges
October 16th 2024The European Union's (EU) approach to biosimilars has revolutionized the biopharmaceutical market by driving innovation, lowering costs, and increasing adoption; however, there remains a need for more education, real-world evidence, and efforts to address challenges to enhance patient access and affordability.
