FDA Approves Second Biosimilar to Remicade

Published on: 

The agency approved Renflexis, a biosimilar to Janssen’s blockbuster rheumatoid arthritis treatment.

On April 21, 2017 FDA announced that it approved Renflexis (infliximab-abda) a biosimilar to Janssen Biotech’s blockbuster Remicade (infliximab). This is the second approved biosimilar for Remicade-Celltrion’s Inflectra (infliximab-dyyb) was approved by the agency in early April 2016. Renflexis also marks the fifth FDA approved biosimilar.

A study published in mAbs comparing Renflexis and Remicade found that the “physicochemical and biological characteristics” of both drugs were similar, with only a few observed differences. The authors noted that these differences most likely would not affect the safety and efficacy of Renflexis. Renflexis was approved for all eligible indications, and it is the first Samsung Bioepis product approved for marketing in the United States, the company said in a press statement.

Remicade is a key product for Johnson & Johnson, and the approval of biosimilar competition like Renflexis and Inflectra may put a dent in J&J’s annual sales. In J&J’s 2016 Annual Report, the company said it anticipates biosimilar competition will reduce Remicade sales in the US. Remicade accounted for approximately 9.7% of J&J’s total revenues in the 2016 fiscal year.


Source: FDA, Samsung Bioepis, Johnson & Johnson