Amgen to start phase III trial for biosimilar adalimumab

Biosimilars/News | Posted 27/09/2013 post-comment2 Post your comment

Biotechnology giant Amgen is to start a phase III clinical trial for a biosimilar version of adalimumab in patients suffering from severe rheumatoid arthritis according to the EU Clinical Trials Register.

Adalimumab V13F21

The drug is a biosimilar version of AbbVie’s blockbuster autoimmune disease treatment Humira (adalimumab). Humira is a tumour necrosis factor (TNF) inhibitor that is approved to treat rheumatoid, juvenile rheumatoid and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

The Amgen study will evaluate the safety and efficacy of Amgen’s biosimilar (ABP 501) versus AbbVie’s Humira in subjects with moderate to severe rheumatoid arthritis.

The trial is a multicentre, double-blind, randomized, active controlled, parallel-group study. The main objective of the study is to demonstrate equivalent efficacy of ABP 501 and Humira (adalimumab) in subjects with moderate to severe rheumatoid arthritis with respect to risk ratio of ACR20 (20% improvement in American College of Rheumatology core set measurements) at week 24.

The trial, which is expected to take 11 months, will be conducted in Argentina, Bulgaria, Canada, Czech Republic, Germany, Hungary, Mexico, Poland, Romania, Russia, Spain, UK and the US and will include 500 patients, aged 18 years and above.

AbbVie’s sales for Humira in 2012 were US$9.3 billion making it a lucrative target for biosimilars manufacturers. The patents on Humira expire in the European Union in 2016 and in the US in 2018 [1].

Pharma giant Pfizer has also started phase I study for its biosimilar adalimumab candidate (PF-06410293) according to the US clinical trials website, [2].

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1.  GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 27]. Available from:

2.  GaBI Online - Generics and Biosimilars Initiative. Pfizer to start trial for biosimilar adalimumab []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 27]. Available from:

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Source: EMA, EU Clinical Trials Register

comment icon Comments (2)
Post your comment
Posted 07/01/2014 by Jodi H, GaBI Online Editorial Office
Response to ‘Patent Expiration Dates are Reversed’

Dear RD,
Thank you for your comment. Please note that the expiration dates are indeed correct as listed: EU to expire in 2016 and US to expire in 2018.
Best regards,

Posted 05/01/2014 by RD
Patent Expiration Dates are Reversed

Should be 2016 for US and 2018 for EU

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