CURA_1170x120_8-22-19

Remicade

Pfizer biosimilar IXIFI approved by FDA

Pfizer biosimilar IXIFI approved by FDA

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

FDA approves Inflectra, the second U.S. biosimilar

FDA approves Inflectra, the second U.S. biosimilar

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

Sandoz biosimilar receives backing of FDA panel

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