Sanofi's Insulin aspart Sanofi® Becomes First Biosimilar to NovoRapid Approved in the EU
Jul 07, 2020 15:37
CST Updated
15:37
Sanofi
Pharmaceutical R&D Developer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
July 07, 2020 News /BioonBIOON/ -- Sanofi recently announced that the European Commission (EC) has approved Insulin aspart Sanofi® (insulin aspart, 100 units/mL) for the treatment of type 1 diabetes in patients aged ≥1 year who require insulin to control blood glucose levels.Diabetesand type 2DiabetesPediatric, adolescent, and adult patients, including those newly diagnosed withDiabetespatients.
This decision was made following the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). This product will provide patients in need with insulin aspart.DiabetesProvides patients with another treatment option.
Insulin aspart Sanofi® is Novo Nordisk’s rapid-acting insulin product, NovoRapid (brand name: Novorapid; generic name: insulin aspart).Biosimilars, the two products are comparable in terms of quality, safety, and efficacy. NovoRapid is a mealtime insulin analogue indicated for the treatment of diabetes in adults, adolescents, and children aged 1 year and older. Additionally, NovoRapid can be used in pregnant women for the treatment of diabetes during pregnancy. In Europe, NovoRapid was approved for marketing on September 7, 1999.
Notably, Insulin aspart Sanofi® is the first aspart insulin approved in the European Union.Biosimilars, enhancing Sanofi’s broad insulin portfolio, which includes two rapid-acting insulin analogs approved by EU regulatory authorities.
EC Approves Insulin Aspart Sanofi® Based on Data from a Clinical Development Program Involving More Than 600 Adult Patients with Type 1 or Type 2 Diabetes. The Program Included a Phase I Pharmacokinetic/Pharmacodynamic (PK/PD) Study to Assess Similarity in Exposure and Activity, as Well as a Multicenter Phase IIIaClinical Trial(Gemelli 12) to evaluate its safety and efficacy.
Each study compared Insulin aspart Sanofi® with NovoRapid (100 units/mL), the insulin aspart product currently approved in the United States and the European Union for adult patients with type 1 or type 2 diabetes. Phase I study data confirmed the similarity between Insulin aspart Sanofi® and NovoRapid in terms of pharmacokinetics (PK) and pharmacodynamics (PD); Phase IIa studies further demonstrated that the two products exhibited comparable glycemic-lowering efficacy and safety profiles over a 26-week treatment period. (Bioon.com)