💊FDA PHARMA TODAY
FDA designates combination therapy with Avermab and inlite (R) for advanced renal cell carcinoma as breakthrough therapy
Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has decided to introduce IXIFI ™ (PF-06438179, infliximab-1), a human / mouse chimeric anti-TNF monoclonal antibody, qbtx) as a biosimilar of Remicade® (Infliximab) *, a leading biopharmaceutical product, with all indications that can be approved for the product.
The FDA has approved IXIFI as a treatment for rheumatoid arthritis, Crohn’s disease in adults and children, adult ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis vulgaris.
http://www.pfizer.co.jp/pfizer/company/press/2018/2018_01_25.html