Celltrion Launches Zymfentra, a Subcutaneous Form of Infliximab

Celltrion USA has launched Zymfentra with a price of $6,181.08 for two shots over four weeks. The FDA had approved Zymfentra (infliximab-dyyb) in October 2023 as the first subcutaneous formulation of infliximab to be used a maintenance therapy for adults with moderate-to-severe active ulcerative colitis and Crohn’s disease.

Celltrion provides commercially insured patients with copay assistance of $5 per month for eligible patients. This is subject to a maximum annual limit, but so far, this limit is not listed on the Zymfentra product site. Patients who are uninsured, underinsured, or lack coverage may be eligible to receive Zymfentra at no cost.

Although Inflectra is an infliximab biosimilar that references Remicade, Zymfentra was approved through the stand-alone biologics license application process. It is considered a new drug due to the subcutaneous administration. It has patent protection through 2037 for its dosage form and 2040 for its route of administration.

The approval was based on phase 3 pivotal data from two studies. Based on the results of the LIBERTY UC and LIBERTY CD studies, Zymfentra met the primary endpoints of clinical remission and endoscopic response as maintenance therapy after induction therapy of intravenous formulation of infliximab. The overall safety profile of Zymfentra was similar to that of placebo during maintenance period in both studies with no new safety signals seen.

Another study, REMSWITCH, investigated the clinical and pharmacological impact of switching from IV to subcutaneous formulation of infliximab in patients with IBD. Results showed switching patients leads to a low risk of relapse in patients.

Results from the two-year extended LIBERTY studies showed long-term efficacy and safety of the subcutaneous administration of infliximab in patients with active Crohn’s disease and ulcerative colitis. These results were presented at the 19th European Crohn’s and Colitis Organization.

Celltrion was the first company to develop a biosimilar of Janssen’s Remicade (infliximab). The FDA approved Inflectra (infliximab-dyyb) in April 2016 to treat patients with several conditions, including Crohn’s, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. Both Remicade and Inflectra are administered by intravenous infusion. Pfizer holds U.S. commercialization rights to Inflectra.