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Pfizer biosimilar IXIFI approved by FDA

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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 colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

In February 2016, Sandoz acquired the rights from Pfizer for the development, commercialization and manufacture of PF-06438179 (infliximab-qbtx) in the 28 European Union member states, as well as three of the four member states of the European Free Trade Association (EFTA) that form the European Economic Area (EEA). Under the divestment, Pfizer retains commercialization and manufacturing rights to the product in countries outside the EEA.

Pfizer has three marketed biosimilars outside the United States, including Inflectra (infliximab), Retacrit (epoetin zeta) and Nivestim (filgrastim), as well as a pipeline of 13 biosimilar molecules in various stages of development. The company noted that as part of its global biosimilars strategy it supplies Celltrion’s Inflectra (infliximab-dyyb) in the U.S. and other international markets.

Other biosimilars approved by the FDA include Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) and Amgen’s Amjevita (adalimumab-atto), both biosimilars of Humira from AbbVie; Samsung Bioepis’ Renflexis (infliximab-abda) and Pfizer/Celltrion’s Inflectra (infliximab-dyyb), biosimilars of Janssen/Johnson & Johnson’s Remicade; Sandoz’s Erelzi (etanercept-szzs), a biosimilar of Amgen’s Enbrel; and Zarxio (filgrastim-sndz), a Sandoz biosimilar of Amgen’s Neupogen.

Zarxio, an oncology medication, was the first FDA-cleared biosimilar product.


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