Monday, June 19, 2017

Abatacept Biosimilars at the 2017 EULAR Annual Meeting in Madrid

The patents on abatacept (Orencia) will expire in Europe in December 2017 and in the US in October 2019 [1]. So I guess the idea isn’t farfetched to look for a biosimilar of abatacept at the 2017 EULAR Annual Meeting in Madrid. I could shorten the story and tell you that hasn’t been any data on abatacept biosimilars EULAR 2017 meeting (I've at every abstract concerning abatacept). But …

In 2014 I found a possible abatacept biosimilar in China [2]: “Leining, a novel cytotoxic T-lymphocyte antigen-4 fusion protein”. Leining had been developed by Shanghai CP Guojian Pharmaceutical. Leining looked like a biosimilar to abatacept (Orencia) to me. In abatacept the extracellular domain of CTLA-4 and the Fc region of the immunoglobulin IgG1 are fused together. As I couldn’t find anything on it, I’ve contacted W. Fan and colleagues to tell us, whether Leining is a biosimilar to abatacept or what else it is. I’ve never received an answer. Leining could well be a biomimic [3]. Adisinsight shows as most recent events [4]:” 5 Mar 2016 - Biomarkers information updated / 24 Mar 2014 - No development reported - Preregistration for Rheumatoid arthritis in China (Parenteral)”. I think we won’t hear more from Leining.

Generics and Biosimilars Initiative (GaBI) reported, that BioXpress Therapeutics (Switzerland) and Momenta Pharmaceuticals/Mylan (USA) are working on abatacept biosimilars [1]. In November 2016 Momentapharm initiated a phase 1 clinical trial to compare the pharmacokinetics, safety and immunogenicity of M834, their on abatacept biosimilar, to US- and EU-sourced Orencia in normal healthy volunteers [5].

So it means that Orencia will have a reprieve without biosimilar competitors.


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