Posted by Michael Wonder on 14 Dec 2017
FDA approves new Pfizer biosimilar
13 December 2017 - Pfizer-developed biosimilar medicine Ixifi (infliximab-qbtx) receives FDA approval for all eligible indications.
Pfizer announced today that the United States FDA has approved Ixifi (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody against tumour necrosis factor, as a biosimilar to Remicade (infliximab) for all eligible indications of the reference product.
The FDA has approved IXIFI as a treatment for patients with rheumatoid arthritis, Crohn's disease, paediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
