Trials to start for biosimilar infliximab and etanercept

Biosimilars/News | Posted 14/06/2013 post-comment0 Post your comment

Pfizer is to start a phase I study for its biosimilar infliximab candidate (PF-06438179) and Samsung Bioepis has initiated a phase III clinical trial for its biosimilar etanercept (SB4), according to entries on the US and EU clinical trials websites.

Clinical Trials V13F14

The Pfizer study will compare the pharmacokinetics of PF-06438179 and infliximab sourced from the US and EU administered to healthy volunteers. The trial is a phase I, double-blind, randomized, parallel-group, single-dose, 3-arm study. The main objective of the study is to demonstrate equivalent pharmacokinetic properties – maximum observed serum concentration (Cmax), area under the curve from time zero to last quantifiable concentration (AUCt) and AUC from time zero extrapolated to infinity (AUC¥) – of PF-06438179 and Remicade (infliximab) over a period of 57 days. The trial will include 129 patients, aged 18 years and above, and is expected to be completed by September 2013.

Pfizer is also carrying out a phase II trial for its rituximab biosimilar (PF-05280586) in the US [1].

The study by South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis will evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB4 compared to Enbrel (etanercept) in subjects with moderate to severe rheumatoid arthritis despite methotrexate therapy.

The trial is a phase III, double-blind, controlled, randomized, parallel-group, 2-arm, multi-centre study. The main objective of the study is to demonstrate the equivalence of SB4 to Enbrel at week 24, in terms of American College of Rheumatology 20% response criteria (ACR 20) response rate in subjects with moderate to severe rheumatoid arthritis despite methotrexate therapy. The trial will be carried out in Bulgaria, Colombia, Czech Republic, Hungary, India, Korea, Lithuania, Mexico, Poland, Ukraine and UK. It will include 498 patients, aged 18 years and above, with 357 coming from the European Economic Area. The trial is expected to last one year and seven months.

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1.  GaBI Online - Generics and Biosimilars Initiative. Development of biosimilars for rheumatology []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 14]. Available from:

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Source:, EU Clinical Trials Register

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