CHMP Expresses Positive Opinions for 2 Insulin Biosimilars

Europe’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for 2 insulin biosimilars, meaning that the agency has recommended the European Commission (EC) grant them marketing authorization.

The opinions are in reference to Inpremzia, a human insulin biosimilar referencing Actrapid, and Truvelog Mix 30, an insulin aspart biosimilar referencing NovoMix 30. The 2 products mark the fifth and sixth approvals for insulin biosimilars for use in the European Union.

More on Truvelog Mix 30

Truvelog Mix 30 was developed by Sanofi-Aventis and is an extension of the original Truvelog (100 U/mL), which was approved for marketing in Europe in June 2020 and references NovoRapid, also known as Novolog in the United States. NovoMix is a Novolog product that contains 30% insulin aspart, an intermediate- or long-acting insulin, and 70% insulin aspart protamine, a fast-acting insulin.

It takes less than 30 minutes to activate once injected, and the peak action is reached in the first 1 to 4 hours and lasts for less than 24 hours. In some countries, NovoMix 30 is marketed as Novolog Mix. A similar product developed by Mylan IRE Healthcare Limited (Kirsty; formerly known as Kixelle) was approved for marketing authorization in the European Union in February 2021.

If granted marketing authorization from the EC, the substance will be available as a 100-U/mL suspension for injection and is indicated for use in adults, adolescents, and children 10 years or older with type 2 diabetes.

The original Truvelog was also approved by the Australian Therapeutic Goods Administration, the Australian equivalent of the FDA and the European Medicines Agency, in October 2020.

More on Inpremzia

Inpremzia was developed by Baxter Holding and is indicated for the treatment of patients with type 2 diabetes. The biosimilar will be available at a 1-IU/mL solution for infusion. Inpremzia is a fast-acting injectable insulin that lowers blood glucose by allowing for glucose to be absorbed into muscle and fat cells, inhibiting glucose output from the liver.

The originator, Actrapid, was approved for use in the European Union in October 2002. The CHMP based its positive opinion on data comparing Actrapid to Inpremzia that demonstrated similar safety and efficacy profiles between the 2 products. Neutral insulin injections like Actrapid and Inpremzia begin lowering the patient’s blood sugar level about 30 minutes after administration and lasts for approximately 8 hours.