EMA recommends approval of Sanofi’s insulin aspart biosimilar

Biosimilars/News | Posted 15/05/2020 post-comment0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 30 April 2020 that it had recommended granting of marketing authorization for an insulin aspart biosimilar.

Diabetes V14K06

The drug is a biosimilar of Novo Nordisk’s NovoLog (insulin aspart). Insulin aspart is a type of manufactured insulin used to treat type 1 and type 2 diabetes. It has a more rapid onset, and a shorter duration of activity than normal human insulin. The positive opinion from EMA’s CHMP recommends the use of Insulin aspart Sanofi to treat adults, adolescents and children aged one year and above who have diabetes and need insulin to keep their blood sugar level controlled, including those patients whose diabetes has just been diagnosed.

The positive CHMP opinion is based on a clinical development programme involving more than 600 adults with type 1 or type 2 diabetes. This programme comprised a pharmacokinetic/pharmacodynamic (PK/PD) phase I study to evaluate the product’s similarity in exposure and activity and a multicentre phase IIIa clinical trial (Gemelli 12) evaluating its safety and efficacy. Each study compared the investigational product to insulin aspart 100 Units/mL as currently approved for use by adults with type 1 or type 2 diabetes in the European Union (EU) and the US.

The CHMP positive opinion will now be considered by the European Commission (EC). Once approved, the EC will grant a centralized marketing authorization for Member countries of the EU. The decision on the EC’s approval is expected in the coming months.

Assuming it receives final EU approval, Insulin aspart Sanofi will be the first insulin aspart biosimilar to receive approval in the EU.

Sanofi already has two rapid-acting insulin analogues approved by European regulators. One is an originator biological, Lantus (insulin glargine). The other is a biosimilar, Insulin lispro Sanofi, which was approved in Europe in July 2017 [1].

US-based drugmaker Mylan has also reported that it is working on an insulin aspart biosimilar, which is ‘on track’ for its US submission in the second quarter of 2020 [2]. According to the EMA’s list of applications for new human medicines under evaluation by the CHMP released on 7 January 2020, the agency is also reviewing a second insulin aspart biosimilar [3].

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 15]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for Mylan’s bevacizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 15]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-Mylan-s-bevacizumab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars applications under review by EMA – January 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 15]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-January-2020

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Source: EMA, Sanofi

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