Biosimilar infliximab comparable to Remicade

The results of the phase III trial in patients with active rheumatoid arthritis were presented at the Annual Congress of the European League Against Rheumatism (EULAR) held in Paris, France, on 11–14 June 2014.

The primary objective of the study was to determine whether BOW015 is equivalent to Remicade in efficacy (as indicated by ACR20 clinical response at week 16), as well as in safety and immunogenicity.

BOW015 achieved a week 16 ACR20 response rate of 89.8%, compared to 86.4% for Remicade, an outcome which met its pre-specified statistical endpoint. The ACR20 is the American College of Rheumatology criteria for clinical improvement in patients with rheumatoid arthritis, indicating a 20% improvement across a series of diagnostic parameters.

The study also included ACR20 comparisons at two, six, and 14 weeks. No other clinical trial of a biosimilar infliximab has demonstrated and reported response to treatment at these earlier time points in advance of the 16 week plateau phase.

Key secondary objectives of the study were to assess long-term efficacy, safety, tolerability, and immunogenicity. No meaningful differences were observed in efficacy, safety and immunogenicity between BOW015 and Remicade.

Results of the open-label phase, including one year immunogenicity, one year safety, and long-term responder rates, are expected to be available in the third quarter of 2014.

Epirus also plans to initiate an additional phase III trial in Europe in early 2015.

Editor’s comment
It should be noted that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

References
1. Bae SC, et al. A randomized, double-blind, phase 3 equivalence trial comparing the etanercept biosimilars, HD203, with Enbrel®, in combination with methotroxate (MTX) in patients with rheumatoid arthritis (RA). EULAR 2014, Paris, France; 11-14 June 2014.
2. GaBI Online – Generics and Biosimilars Initiative. Merck enters biosimilars deal with Korea’s Hanwha [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jul 4]. Available from: www.gabionline.net/Biosimilars/News/Merck-enters-biosimilars-deal-with-Korea-s-Hanwha

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Source: www.gabionline.net