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.

Related article
EMA approval for etanercept and rituximab biosimilars

Reference
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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