Sanofi's Insulin Aspart Sanofi® (100 U/mL) Set for EC Approval in June as EU’s First Insulin Aspart Biosimilar
May 05, 2020 16:38
CST Updated
16:38
Sanofi
Pharmaceutical R&D Developer
European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
May 05, 2020 News /BioonBIOON/ -- Sanofi recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of 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.
It is worth noting that this positive review opinion is the European Union's first for any insulin aspartBiosimilars's first regulatory milestone. Sanofi already has two rapid-acting insulin analogs approved by EU regulatory authorities.
The CHMP opinion will now be submitted to the European Commission (EC) for review, which typically issues its final decision within two months.
Sandra Silvestri, M.D., Global Head of Medical Affairs for Sanofi’s General Medicines division, stated: “For patients who need rapid blood glucose control during mealsDiabetesFor patients, insulin aspart is an important and widely used treatment. The one we developedBiosimilars"reflects Sanofi's expertise and tradition in developing and manufacturing insulin for patients with type 1 or type 2 diabetes and their physicians."
The CHMP recommends approval of 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 Trials(Gemelli 12), to evaluate its safety and efficacy. Each study compared the investigational drug with insulin aspart (100 units/mL), which is currently approved in the United States and the European Union for adults with type 1 or type 2 diabetes.
Cyril Grandchamp-Desraux, Global Head of Diabetes at Sanofi’s Generic Medicines division, stated: “We welcome the CHMP’s positive opinion on Insulin aspart Sanofi® and look forward to the European Commission’s (EC) final decision. By expanding the range of biosimilar rapid-acting insulins within our portfolio of high-quality insulin products, we continue to demonstrate our commitment to enhancing the affordability and sustainability of insulin therapy.” (Bioon.com)
Original source: Sanofi receives CHMP recommendation forapproval of insulin aspart biosimilar