Pfizer reports positive outcome from study of infliximab biosimilar

Pfizer has announced positive findings from REFLECTIONS B537-02, a study assessing its new biosimilar version of infliximab.

The trial demonstrated that the proposed biosimilar PF-06438179 offered equivalent efficacy to the originator product when used in combination with methotrexate among patients with moderate to severely active rheumatoid arthritis.

The study is also designed to evaluate the drug's clinical response, safety and immunogenicity among patients transitioning from Remicade, the original version of infliximab, to PF-06438179 after 30 or 54 weeks of Remicade treatment.

Remicade was originally developed by Janssen and is currently approved in the US and EU for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

Pfizer is seeking to demonstrate that PF-06438179 can offer an equivalent performance in all of these indications, allowing the biosimilar to be sold as a lower-cost alternative to the brand-name original.

Sandoz has rights to the development, commercialisation and manufacture of PF-06438179 in Europe, with Pfizer continuing to handle these responsibilities outside the European Economic Area.

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