BioCentury
ARTICLE | Regulation

Extrapolating mAbs

What FDA panel's review of Remicade biosimilar means for other biosimilar mAbs

February 22, 2016 8:00 AM UTC

FDA's Arthritis Advisory Committee's discussion and vote to recommend approval of the first biosimilar mAb shows that the mechanism of action of the reference product matters, and companies with biosimilars of mAbs approved for multiple indications based on varying MOAs will need to come armed with ample analytical data to support extrapolation across the different diseases.

On Feb. 9, the panel voted 21-3 to support approval of Celltrion Inc.'s Inflectra (CT-P13), a biosimilar of Remicade infliximab across seven of the eight indications for which the Johnson & Johnson drug is approved: rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, ulcerative colitis and adult and pediatric Crohn's disease. ...