Statement on the Food and Drug Administration (FDA) Arthritis Advisory Committee Meeting on Infliximab Biosimilar

Pfenex applauds the FDA’s Arthritis Advisory Committee for recommending approval of Celltrion Inc.’s infliximab biosimilar, CT-P13, with full extrapolation to all indications. Infliximab currently exists in the US only as the branded biologic Remicade, and the addition of another treatment on the market could provide thousands of patients across the nation with access to a more affordable, and equally-effective alternative. Other geographies such as Europe—which already has more than 20 approvals—are reaping the benefits of the significantly improved patient access and healthcare savings that biosimilars provide. The recommended approval of CT-P13 from the FDA’s Arthritis Advisory Committee is a step toward creating a robust biosimilars market in the United States, which could significantly reduce our healthcare costs, while increasing patient access to life-changing therapeutics. We applaud the Committee for taking this step to bring the second biosimilar to the U.S. market and hope that, with additional guidance from the FDA, the biosimilars market will continue to grow.