US-based Epirus Biopharmaceuticals (Epirus) announced on 23 September 2014 positive week 58 follow-up data from its global phase III study for its biosimilar infliximab (BOW015). Results of the open label phase, which was carried out in rheumatoid arthritis patients, demonstrated comparable safety and efficacy compared to the originator product (Remicade).
According to Dr Michael Wyand, Senior Vice President of clinical, regulatory and manufacturing at Epirus, ‘the open label phase of the study was designed to provide data on the long-term safety and durability of response as well as long-term safety for Remicade responders switching to BOW015. This data suggests the patients can safely be started and maintained on BOW015 and that patients can be safely switched from Remicade to BOW015.’
Results of the initial 16-week part of the phase III trial demonstrated the comparability of US-based Epirus Biopharmaceuticals (Epirus) biosimilar infliximab (BOW015) to Remicade for the treatment of rheumatoid arthritis. These results were presented at the Annual Congress of the European League Against Rheumatism (EULAR) held in Paris, France, on 11–14 June 2014 [1].
In the open-label phase, patients who continued on BOW015 were compared to patients who received four doses of Remicade, followed by a switch to four doses of BOW015. Immune responses, as well as overall safety and tolerability, for BOW015 were comparable to the arm switched from Remicade to BOW015 and were consistent with the expected profile of Remicade. Further, ACR20 responses were durably maintained to 58 weeks from the week 16 primary endpoint previously reported. 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.
Johnson & Johnson’s originator product, Remicade, is indicated for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis. Remicade had worldwide sales of US$9.27 billion in 2013, making it the world’s best-selling medicine and a lucrative target for biosimilars developers.
Epirus received final marketing and manufacturing approvals for its infliximab ‘similar biologic’, BOW015, from the Drug Controller General of India (DCGI) in September 2014 [2]. The company also plans to initiate an additional phase III trial in Europe in early 2015.
Editor’s comment
It should be noted that these results were 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.
It should be noted that ‘similar biologics’ approved in India 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. GaBI Online - Generics and Biosimilars Initiative. Biosimilar infliximab comparable to Remicade [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 31]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilar-infliximab-comparable-to-Remicade
2. GaBI Online - Generics and Biosimilars Initiative. Infliximab ‘similar biologic’ receives Indian approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 31]. Available from: www.gabionline.net/Biosimilars/News/Infliximab-similar-biologic-receives-Indian-approval
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