Subcutaneous Infliximab Biosimilar Approved

The US Food and Drug Administration on October 23 approved infliximab-dyyb (Zymfentra), the  first and only subcutaneous infliximab product, for the treatment of adults with moderate to severe inflammatory bowel disease following treatment with intravenous infliximab.

The agency’s decision was based on data from 2 phase 3 pivotal trials that assessed the efficacy of subcutaneous infliximab-dyyb as maintenance therapy in patients with moderate to severe ulcerative colitis (UC) and Crohn’s disease (CD). Data on the LIBERTY-UC and LIBERTY-CD trials were presented at the European Crohn’s and Colitis Organization congress.

In these trials, subcutaneous infliximab-dyyb demonstrated superior response in achieving clinical remission in both UC and CD, and endoscopic response in CD, compared to placebo as maintenance therapy after induction therapy of intravenous infliximab over a 54-week period. The overall safety profile of subcutaneous infliximab-dyyb was similar to that of placebo during the maintenance period in both studies, and no new safety signals were identified.

The intravenous infliximab biosimilar was approved by the EU in 2013 under the for the treatment of CD, UC, and 6 other autoimmune diseases. It was approved in the US by the FDA in 2016. Both the IV and subcutaneous formulations are manufactured in the US by Celltrion.