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myl-1601d
- Development stage
- Phase 3
- Lead developer
- Viatris
- Modality
- Recombinant Proteins and Enzymes
- Administration
- Subcutaneous, Intravenous
01
Overview
MYL-1601D is a biosimilar of insulin aspart, developed to closely match the originator products NovoLog (US) and NovoRapid (EU). It is a rapid-acting recombinant human insulin analog produced using recombinant DNA technology in Pichia pastoris yeast. MYL-1601D is indicated for improving glycemic control in adults and pediatric patients with diabetes mellitus. Clinical studies have demonstrated that MYL-1601D has similar immunogenicity, efficacy, and safety profiles compared to reference insulin aspart when used at mealtimes in combination with basal insulins such as insulin glargine. The product provides an alternative treatment option for patients requiring rapid-acting prandial insulin therapy[1][2][3][5].
- Brand names
- Kixelle
- Other names
- insulin aspart biosimilarinsulin aspart solution 100 U/mL
02
Targets
INSR (Insulin receptor)
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