EMA approval for insulin and rituximab biosimilars

Biosimilares/Novedades | Posted 26/05/2017 post-comment0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 19 May 2017 that it had recommended granting marketing authorization for Insulin lispro Sanofi and for the rituximab biosimilars Blitzima, Ritemvia and Tuxella.


The insulin lispro biosimilar, which is produced by Sanofi, was recommended for approval for the treatment of diabetes mellitus. The recommendation is based on a clinical development programme involving over 1,000 adults with type 1 or type 2 diabetes. This programme included a phase I pharmacokinetic/pharmacodynamic (PK/PD) study, two multicentre phase IIIa clinical trials (SORELLA 1 and SORELLA 2) evaluating its safety and efficacy compared to insulin lispro 100 units/mL as currently approved in the US and EU in adults with type 1 or type 2 diabetes, and a safety study in insulin pumps in adults with type 1 diabetes.

All three rituximab biosimilars are produced by South Korean biotechnology company Celltrion. Blitzima, Ritemvia and Tuxella are biosimilars of Roche’s MabThera/Rituxan (rituximab), a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders.

EMA’s CHMP has recommended that Blitzima and Tuxella be approved for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, granulomatosis with polyangiitis and microscopic polyangiitis. The committee recommended that Ritemvia be approved for the treatment of non-Hodgkin’s lymphoma, granulomatosis with polyangiitis and microscopic polyangiitis.

Celltrion already has a rituximab biosimilar approved by EMA – Truxima [1]. The four-name strategy is believed to be a tactic to generate greater total market share for its biosimilar and allow Celltrion to hand out distribution rights to several different companies. The company has already used a similar strategy for its infliximab biosimilar, which has two names – Inflectra and Remsima – with Hospira using Inflectra and Celltrion Remsima.

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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 2017 May 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: EMA, Sanofi

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