Biocon Biologics announced last week that they received FDA approval for a new biosimilar version of insulin aspart which they have dubbed Kirsty (insulin aspart-xjhz). The FDA has granted Biocon Biologics the interchangeability designation for automatic substitution with the reference product NovoLog.
Biocon Biologics first applied for approval of this product in July 2020. The five-year journey to commercialization ends with the approval of this second insulin aspart product, the first being a Sanofi product called Merilog, which received approval in February 2025. Unlike insulin glargine, which has four biosimilar competitors (and a 38% marketshare) and Basaglar, a 505b(2) agent, the aspart category has not yet generated more biosimilar options. Only Sandoz has a 351(k) application outstanding.
As with Kirsty, Biocon Biologics’ insulin glargine product, Semglee, was acquired through Mylan/Viatris. Semglee has been offered as a low- and high-WAC pricing option, and currently has roughly 7% marketshare in this category (6% as an unbranded version). It was first approved in June 2020 as a 505(b)2 product, before subsequently being designated as an interchangeable biosimilar. Biocon has not announced its pricing for Kirsty. Â
Kirsty will be available in single-use 3-mL prefilled pens and multidose, 10-mL vials. The company noted that the drug may be diluted for subcutaneous injection in circumstances when very small doses are required although these are rare circumstances.
In Other Biosimilar News
On July 16, Bio-Thera Solutions and its commercialization partner Accord BioPharma received confirmation from the FDA that its 351(k) application for BAT2506, a proposed golimumab biosimilar (reference product, Simponi), has been accepted. An FDA decision on BAT2506 is expected in Q2 2026. This marks the second FDA submission for a golimumab biosimilar, with Alvotech and Teva filing in January 2025.
