The European Commission (EC) has granted marketing authorization for the insulin aspart biosimilar Kixelle (MYL 1601D), developed by US-based drugmaker Mylan (now Viatris) and India-based biologicals specialist Biocon.
Kixelle is a proposed biosimilar to Novo Nordisk’s NovoLog/NovoRapid/NovoMix (insulin aspart). Novo Nordisk reported estimated sales of Euros 1.8 billion (DKK 1.4 billion) globally for NovoRapid in 2019 [1]. NovoLog/NovoRapid/NovoMix no longer has effective exclusivity through patent protection or data protection in either Europe or the US [2].
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 insulins.
The approval by the EC on 5 February 2021 follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation during its meeting, which took place on 7–10 December 2020. The CHMP recommended at that meeting that Kixelle be approved for the treatment of diabetes mellitus.
Kixelle is the second insulin aspart biosimilar to receive approval in the EU. Insulin aspart Sanofi received marketing approval in Europe on 25 June 2020 [3]. The centralized marketing authorization granted by the EC is valid in all European Union Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.
According to EMA’s list of applications for new human medicines under evaluation by the CHMP released on 15 January 2020, the agency is reviewing a third insulin aspart biosimilar [4].
Mylan and Biocon made an agreement back in February 2013 to develop and market Biocon’s biosimilar versions of three insulin analogue products, which included versions of Sanofi’s Lantus (insulin glargine), Eli Lilly’s Humalog (insulin lispro) and Novo Nordisk’s NovoLog (insulin aspart) [5].
Mylan also mentioned in its quarterly earnings call that it was ‘on track’ for its US submission in the second quarter of 2020 for its insulin aspart biosimilar [6].
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| LATIN AMERICAN FORUM – Coming soon! To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America. Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM – Próximamente! Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica. Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.
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References
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2. Derbyshire M, Shina S. Patent expiry dates for best-selling biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
3. GaBI Online - Generics and Biosimilars Initiative. EC approval for Sanofi’s insulin aspart biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 26]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-Sanofi-s-insulin-aspart-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar applications under review by EMA – January 2021 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-January-2021
5. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon to partner on insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 26]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-to-partner-on-insulin-products
6. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for Mylan’s bevacizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 26]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-Mylan-s-bevacizumab-biosimilar
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