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Biosimilars of abatacept Posted 02/12/2016

Last update: 28 April 2017

Abatacept is a modified antibody biological drug used to treat autoimmune diseases like rheumatoid arthritis, by interfering with the function of particular cells (T-cells) in the immune system. This action modifies the inflammation and immune activity which cause the symptoms of rheumatoid arthritis.

Abatacept is a fusion protein composed of the Fc region of the immunoglobulin IgG1 fused to the extracellular domain of CTLA-4. In order for a T-cell to be activated and produce an immune response, an antigen-presenting cell must present two signals to the T-cell. One of those signals is the major histocompatibility complex (MHC), combined with the antigen, and the other signal is the CD80 or CD86 molecule (also known as B7-1 and B7-2). Abatacept binds to the CD80 and CD86 molecule, and prevents the second signal. Without the second signal, the T-cell cannot be activated.

The originator product, Bristol-Myers Squibb’s Orencia (abatacept), was approved by the US Food and Drug Administration (FDA) in December 2005 and by the European Medicines Agency (EMA) in May 2007 [1]. Orencia had sales of US$1.9 billion in 2015.

The patents on Orencia will expire in the US in October 2019 and in Europe in December 2017 [1]. Some of the abatacept biosimilars and non-originator biologicals* approved or in development are presented in Table 1.

Table 1: Biosimilars and non-originator biologicals* of abatacept approved or in development

Company name, Country

Product name

Stage of development

BioXpress Therapeutics, Switzerland

-

In pipeline

Momenta Pharmaceuticals/Mylan, USA

M834

Momenta and Mylan are collaborating on six biosimilars [2]. Phase I trial initiated in November 2016

*See editor’s comment

No biosimilars makers are very far along the road to developing an abatacept biosimilar, despite the fact that the patents on the originator product expire in 2017, this highlights the costs involved and complexity in developing biosimilars.

Editor’s comment
It should be noted that ‘non-originator biologicals’ approved in less regulated countries might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

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References
1. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
2. GaBI Online - Generics and Biosimilars Initiative. Mylan and Momenta to jointly develop and commercialize six biosimilar products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 2]. Available from: www.gabionline.net/Pharma-News/Mylan-and-Momenta-to-jointly-develop-and-commercialize-six-biosimilar-products

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Source: ClinicalTrials.gov, EMA, US FDA

Comments (1)

Other Developers posted 03/02/2017 - by Ronald A. Rader

Other developers of biosimilar abatacept (if they count, being based in China, which has no precedents at all yet for major market biopharmaceutical approvals) include Innovent Biologics, Inc and Shanghai CP Guojian Pharmaceutical Co Ltd. If they succeed fully and document analytical and clinical biosimilarity and attain GMP manufacturing, these could be targeted to major markets.

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