Centocor, Inc (HORSHAM, Pennsylvania), a wholly-owned subsidiary of Johnson & Johnson, announced that a Biologics License Application (BLA) has been submitted to the US FDA requesting the approval of golimumab, a human anti-TNFα monoclonal antibody, as a monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). In February 2008, Centocor submitted a Marketing Authorization Application to the European Medicines Agency also requesting approval of the antibody for the same dosing regimen and indications.

Golimumab, which targets and neutralizes both the soluble and membrane-bound forms of TNFα, is currently in the most comprehensive phase III development program to date for an anti-TNFα biologic.

Five pivotal phase III trials support the BLA: GO-BEFORE, GO-FORWARD, and GO-AFTER, which were recently presented at the EULAR Annual Congress, as well as GO-REVEAL, and GO-RAISE , whose primary endpoint findings were reported at the ACR Annual Scientific Meeting in November 2007.

Centocor discovered golimumab and has exclusive marketing rights to the product in the US. Pending regulatory approval, Schering-Plough Corp will assume exclusive marketing rights outside the US except in Japan, Indonesia, and Taiwan where golimumab will be co-marketed by Mitsubishi Tanabe Pharma Corp and Janssen Pharmaceutical Kabushiki Kaisha. In Hong Kong, golimumab will be exclusively marketed by Janssen-Cilag; in China golimumab will be exclusively marketed by Xian-Janssen.