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.

Links and References: 
[1] http://www.gabionline.net/Biosimilars/General/Biosimilars-of-abatacept 
[2] http://rheumatologe.blogspot.de/2014/11/leining-novel-cytotoxic-t-lymphocyte.html 
[3] http://rheumatologe.blogspot.de/2016/08/bioidenticals-biosimilars-biologics.html 
[4] http://adisinsight.springer.com/drugs/800039891 
[5] http://www.momentapharma.com/pipeline/development-programs.php

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