Insulin aspart biosimilars

Recombinant human insulin analogue in which proline at position B28 is replaced by aspartic acid, produced in Saccharomyces cerevisiae for the reference product. The substitution reduces the tendency of insulin molecules to form hexamers, so the monomer is absorbed faster after injection.

Binds the insulin receptor on muscle, fat and liver cells and lowers blood glucose by promoting glucose uptake and suppressing hepatic glucose output. Its pharmacology is that of human insulin; the difference is the speed of absorption from the subcutaneous depot.

Onset of action within 10 to 20 minutes of subcutaneous injection, peak effect at one to three hours and duration of three to five hours, so it is injected immediately before meals. It is also used in insulin pumps and, in the biphasic 30/70 formulation with protamine, as a twice-daily premix.

Individually titrated to meals and blood glucose, at 100 units/mL in 10 mL vials, 3 mL cartridges and pre-filled pens. Biphasic insulin aspart 30 (30% soluble, 70% protamine-crystallised) is a separate premix presentation with its own approvals.

• Diabetes mellitus in adults, adolescents and children from 1 year of age (EU) or 2 years (United States)
• Continuous subcutaneous insulin infusion by pump
• Biphasic 30/70 premix: type 1 and type 2 diabetes requiring mealtime and basal cover

Anti-insulin antibodies cross-react between aspart and human insulin and are seldom clinically relevant. Comparative programmes use analytical similarity, pharmacokinetic and pharmacodynamic equivalence in euglycaemic clamp studies, a comparative immunogenicity and safety study in type 1 diabetes, and full device and pump-compatibility testing.

NovoRapid was authorised in the EU on 7 September 1999 (EMEA/H/C/000258) and NovoLog approved by FDA in June 2000 (NDA 020986), deemed a biologics licence when insulins transitioned to the BLA framework on 23 March 2020. Sanofi's biosimilar was the first in the EU in June 2020 and, as Merilog, the first in the US in February 2025; Biocon's Kirsty followed in both markets and became the first interchangeable insulin aspart in July 2025. Gan & Lee's Dazparda was authorised in the EU in April 2026.

Sources: Purple Book (S016), EMA medicines data (S017), CDSCO lists (S011, S012, S013).

Insulin aspart is the mealtime companion to glargine, and the two biosimilar sets come from the same developers: Biocon, Sanofi, Gan & Lee. The US market opened only in 2025, Sanofi's EU premix was withdrawn in 2024, and Biocon's Kirsty is registered in the UAE from its Malaysian site. In India, Biogenomics received the first domestic permission in October 2021 and added the biphasic premix in 2025, while Sanofi imports its premix.