FDA Approves First Subcutaneous Infliximab for IBD

The FDA has approved Celltrion USA’s Zymfentra (infliximab-dyyb), the first subcutaneous formulation of infliximab to be used a maintenance therapy for adults with moderately to severely active ulcerative colitis and Crohn’s disease.

Zymfentra is a subcutaneous version of infliximab. 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 novel subcutaneous administration. Celltrion will release the list price closer to when the product is available, according to a spokesperson.

"Celltrion USA is committed to providing patients with high quality medicines that address unmet medical needs and we will endeavor to make them available to the patients who need the," the spokesperson said.

Thomas Nusbickel

“There remains an unmet need for patients who suffer from the day-to-day burden of living with moderately to severely active Crohn’s disease and ulcerative colitis,” Thomas Nusbickel, chief commercial officer at Celltrion USA, said in a press release. “The approval of Zymfentra provides an innovative and effective treatment option that offers patients with IBD an alternative administration option providing control of how and where they receive their treatment.”

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 demonstrated superiority over placebo in 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.

Additionally, a post-hoc analysis of a pivotal phase 3 trial shows that the subcutaneous formulation of infliximab is associated with significantly greater improvements in clinical outcomes compared with the intravenous formulation of infliximab at week 30, in patients with rheumatoid arthritis. Between-group differences were reduced at week 54, suggesting improved responses after switching.

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, which is approved for several indications, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis and psoriatic and plaque arthritis.

Related: Subcutaneous IBD Drugs Could Tip Chunk of Drug Spend to the Pharmacy Benefit | AMCP Nexus 2023

The approval of the subcutaneous formulation could shift market share from the medical to the pharmacy benefit because it will be self-administered at home instead of being of being delivered as an infusion in a doctor's office or clinic, Aimee Tharaldson, Pharm.D., clinical program principal, emerging therapeutics at Evernorth, said last week, at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 meeting in Orlando.