Pfizer has obtained approval from the US Food and Drug Administration (FDA) for its IXIFI (PF-06438179, infliximab-qbtx) as a biosimilar to Remicade (infliximab) for all eligible indications.
IXIFI, which is a chimeric human-murine mAb that targets tumour necrosis factor, has been indicated for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and paediatric Crohn’s disease.
The firm divested the development, commercialisation and manufacturing rights of IXIFI to Sandoz in February last year.
Under the divestment terms, Sandoz holds the rights in 28 EU member states and the European Economic Area (EEA), which includes Iceland, Liechtenstein and Norway.
Pfizer, however, retains these rights in countries outside the EEA.
The FDA approved IXIFI based on the overall results obtained during the multi-national, randomised, double blind, two-arm, parallel group Phase III REFLECTIONS B537-02 trial conducted in subjects with moderate-to-severe active rheumatoid arthritis.
Results indicated high degree of similarity between IXIFI and the reference product Remicade, which was given as an intravenous injection combined with methotrexate.
Performed to assess the safety, efficacy and immunogenicity of IXIFI, the trial met its primary endpoint of ACR20 response at week 14.
Outside the US, Pfizer markets three biosimilar medicines, INFLECTRA (infliximab), Retacrit (epoetin zeta) and Nivestim (filgrastim).
In addition, the firm’s portfolio includes a biosimilars pipeline with 13 distinct biosimilar molecules that are in different stages of development.
The firm also markets Celltrion’s INFLECTRA (infliximab-dyyb) in select markets, including the US.