FDA gives nod to infliximab biosimilar
medwireNews: PF-06438179 (infliximab-qbtx), an infliximab biosimilar, has been approved in the USA for the same indications as its reference product.
The tumor necrosis factor inhibitor is indicated for the treatment of patients with rheumatoid arthritis (RA), ankylosing spondylitis, and psoriatic arthritis, in addition to those with plaque psoriasis, ulcerative colitis, and Crohn’s disease.
This approval is based on evidence demonstrating a high degree of similarity between PF-06438179 and infliximab, including a phase III study showing comparable efficacy, safety, and immunogenicity profiles in patients with moderate-to-severe RA who were receiving background methotrexate treatment.
PF-06438179 and its reference product are given as an intravenous infusion, and carry a boxed warning for serious infection and malignancy risk.
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