April 2016

Biosimilar Update – Shall We Dance?

By: Emily A. Curtis  |   April 20, 2016

On April 5, 2016, the U.S. Food and Drug Administration (“FDA”) approved Inflectra, Celltrion Inc.’s biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab). Inflectra was approved as therapy for Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic severe plaque psoriasis. This is the second biosimilar approved by the FDA following the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). Although the FDA just approved Inflectra, Janssen and Celltrion have already begun patent litigation related to the biosimilar. Litigation is related to Janssen’s patents and Celltrion’s statutory requirements under BPCIA.