NEW YORK — Pfizer Inc. has received approval from the Food and Drug Administration for IXIFI (infliximab-qbtx), a biosimilar of Remicade (infliximab) from Janssen Biotech Inc. Pfizer said the FDA cleared IXIFI, a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, for the treatment of patients with rheumatoid arthritis, Crohn’s disease, pediatric Crohn’s disease, ulcerative
WASHINGTON — Just over a year after approving its first biosimilar product, the Food and Drug Administration has approved its second, Celltrion’s Inflectra (biosimilar infliximab). Inflectra is a biosimilar to Janssen Biotech’s Remicade (infliximab), originally licensed in 1998. Inflectra is indicated for reducing signs and symptoms in patients with rheumatoid arthritis, adult ulcerative colitis, plaque
WASHINGTON — A Food and Drug Administration panel has recommended that the agency approve what could become the country’s first biosimilar. The panel unanimously urged approval of Sandoz’s filgrastin (Neupogen), a cancer treatment. “This encouraging step forward means that it is very likely now only a question of when, rather than if, filgrastin will be available
