Non-clinical study shows similarity of biosimilar etanercept

Biosimilars/Research | Posted 29/11/2013 post-comment0 Post your comment

The results of a non-clinical study of a candidate biosimilar etanercept (GP2015) has shown the similarity, with respect to in vitro and in vivo characteristics, of the biosimilar (GP2015) and its reference product, Amgen’s blockbuster autoimmune disease treatment Enbrel (etanercept).

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Enbrel is a tumour necrosis factor (TNF) inhibitor that is approved to treat rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

Sandoz, the generic drug division of Swiss drug giant Novartis, presented the results of the study at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in San Diego, USA, which was held on 26–30 October 2013 [1].

At the in vitro level, comparable binding affinities for the biosimilar and originator etanercept to TNF-α and Fc leukocyte receptors, as well as functional inhibition of TNF-α and lymphotoxin alpha (LTα), were observed. Data from preclinical models also confirmed in vivo comparability for the proposed biosimilar etanercept (GP2015), in terms of both pharmacokinetics and efficacy.

This non-clinical similarity exercise confirms that the candidate biosimilar etanercept (GP2015) and the reference medicinal product are pharmacologically similar with regard to target binding, anti-TNF-α biological activity and pharmacokinetic exposure. Future clinical trial(s) are needed to provide evidence of similar efficacy and safety of GP2015 to that of the originator product. Sandoz is planning to start a phase III clinical trial for a biosimilar version of etanercept in patients suffering from psoriasis, according to the EU Clinical Trials Register [2].

In the US, the patent on Enbrel was originally set to expire on 23 October 2012, but an extension of the patent, for another 16 years, has been granted. This means that in the US the patent on Enbrel will only expire in 2028, whereas in the European Union the patent will expire on 1 February 2015 [3]. Sales of Enbrel for 2012 were US$4.2 billion, making it a lucrative target for biosimilars developers.

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Etanercept biosimilar has comparable pharmacokinetics to Enbrel


1.  da Silva A. Target-directed development of a proposed biosimilar Etanercept, GP2015: comparability of in vitro target binding and pre-clinical efficacy and pharmacokinetics. American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting, San Diego, US, 26-30 October 2013. Abstract:#1736.

2.  GaBI Online - Generics and Biosimilars Initiative. Sandoz to start phase III etanercept trial []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 29]. Available from:

3.  GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 29]. Available from:

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Source: ACR

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