Kixelle (insulin aspart biosimilar) / Viatris, Biocon, Civica - LARVOL DELTA

Biocon Biologics and Civica, Inc. Collaborate to Expand Insulin Aspart Access in the United States (Biocon Press Release) - "Biocon Biologics Ltd ...and Civica, Inc...today announced a strategic collaboration agreement to expand access and affordability of Insulin Aspart in the United States...Under the terms of the agreement, Biocon Biologics will supply Insulin Aspart drug substance to Civica, Inc., who will use the drug substance to produce Insulin Aspart drug product, a rapid-acting insulin analog, at its manufacturing facility in Petersburg, Virginia. Civica will commercialize the medicine for patients in the United States, after completion of development work and clinical trials. No technology transfer is involved in the agreement."

Commercial • Diabetes

Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Aspart (MYL-1601D) Compared with Originator Insulin Aspart (Novolog) in Patients with Type 1 Diabetes After 24 Weeks: A Randomized Open-Label Study. (PubMed, BioDrugs) - P3 | "MYL-1601D demonstrated similar immunogenicity, efficacy, and safety profiles to Ref-InsAsp-US in patients with T1D over 24 weeks. CLINICAL TRIAL REGISTRATION CLINICALTRIALS.GOV: NCT03760068."

Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

Pharmacokinetic and Pharmacodynamic Bioequivalence of Biosimilar MYL-1601D with US and European Insulin Aspart in Healthy Volunteers: A Randomized Double-Blind, Crossover, Euglycemic Glucose Clamp Study. (PubMed, Diabetes Obes Metab) - "MYL-1601D demonstrated bioequivalence to Ref-InsAsp-US and Ref-InsAsp-EU with a comparable safety profile."

Clinical • Journal • PK/PD data