FDA Approves First-of-its-Kind Subcutaneous Infliximab Biosimilar

The FDA has approved infliximab-dyyb (Zymfentra, Celltrion), the first and only subcutaneous formulation of infliximab approved for the maintenance treatment of adult patients with moderately to severely active ulcerative colitis (UC) and Crohn disease (CD) following intravenous administration of an infliximab product.¹

Celltrion’s intravenous version of Zymfentra is marketed as Inflectra, which was approved April 2016 and launched on the US market November 2016. There are 2 other intravenous infliximab biosimilars on the market in the United States: Renflexis from Organon/Samsung Bioepis, approved May 2017 and launched July 2017, and Avsola from Amgen, approved December 2019 and launched July 2020.

The drug works by blocking the action agent of tumor necrosis factor-alpha, a protein that can be overproduced in response to certain diseases and may trigger the immune system to attack healthy parts of the body.

The approval of infliximab-dyyb comes after the evaluation of data gleaned from the randomized, placebo-controlled, double-blind, phase 3 LIBERTY-UC and LIBERTY-CD studies that demonstrated superiority in the primary end points of clinical remission (UC and CD) and endoscopic response (CD) compared with placebo after induction therapy of intravenous formulation of infliximab in patients with UC and CD over a 54-week study period.

“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, reinforcing our commitment to providing high-quality and affordable treatment options that deliver substantial value to patients and our healthcare system.”

Although the safety profile during maintenance phase was found to be generally comparable between infliximab-dyyb and placebo arms in both the UC and CD studies, adverse events were observed in each. The most common of these included COVID-19, upper respiratory tract infection, headache, injection site reactions (CD), and anemia, arthralgia, increased alanine aminotransferase, and abdominal pain (UC).

The novel infliximab-dyyb offers an innovative administration option to patients with severe inflammatory bowel disease (IBD), a term used to reference both UC and CD, granting them more autonomy in determining their treatment regimen. Doctors like Jean-Frederic Colombel, MD, of Icahn School of Medicine at Mount Sinai and Andres Yarur, MD, of Cedars-Sinai Medical Center have cited the convenience, improved accessibility, efficacy, and safety of the newly approved monoclonal antibody biosimilar as critical advances in the ongoing efforts to improve the lives of patients with IBD.

“As a healthcare professional dedicated to improving the lives of patients with IBD, I am excited to see further data that validate a convenient treatment option that could allow more patients in the U.S. to have greater control of their disease management,” said Colombel.

Reference

1. Celltrion USA announces U.S. FDA approval of Zymfentra (infliximab-dyyb), the first and only subcutaneous infliximab, for the treatment of people with inflammatory bowel disease. Celltrion USA. News release. October 23, 2023. https://www.celltrionhealthcare.com/board/en_newslist/109