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The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
In late October 2023, the FDA approved Zymfentra (infliximab-dyyb), the world's first subcutaneous infliximab product. The product's development was based on Inflectra (infliximab-dyyb), an intravenous infliximab biosimilar referencing Remicade (infliximab). However, because the reference product does not have a subcutaneous option, Zymfentra was approved as a novel agent.
Zymfentra is also approved in Europe, where it's marketing under a different brand name. The product was developed by Celltrion, a Korean biopharmaceutical manufacturer that's shaping up to be a big player in the US biologics space. Zymfentra's subcutaneous presentation allows for easier and more convenient self-administration for patients, particularly those with inflammatory bowel disease (IBD), an umbrella term for ulcerative colitis and Crohn disease.
Zymfentra is also unique in that it was approved using data from 2 trials testing the product vs placebo in patients with ulcerative colitis and Crohn disease. Typically, infliximab biosimilars are tested in patients with RA or PsA and receive extrapolated indication for gastroenterology conditions. The LIBERTY trials offer gastroenterologists who may be wary of a subcutaneous infliximab option a degree of confidence that Zymfentra is safe and effective for patients currently on intravenous infliximab treatments.
We spoke with Andres Yarur, MD, a researcher on the LIBERTY trial and an associate professor of medicine at Cedars-Sinai Medical Center, to discuss the significance of his trial, the approval of a subcutaneous infliximab option, and what both mean for the future of IBD care.
Show notes
To learn more about the FDA approval of Zymfentra, click here.
To learn more about the results from the LIBERTY trials, click here.
Comparable Disease Activity, Drug Persistence in Patients With JIA Who Switch to Biosimilars
September 12th 2024Switching children with juvenile idiopathic arthritis (JIA) from anti-tumor necrosis factor (TNF) originators to biosimilars showed similar disease activity and drug persistence, with good tolerability, supporting the safety and effectiveness of non-medical switching.
BioRationality: FDA Clarification Provides New Indications and Process Change for Biosimilars
September 9th 2024Sarfaraz K. Niazi, PhD, explains the FDA's new guidelines on post-approval changes for biosimilars, emphasizing the processes for reporting modifications, comparability assessments, and the potential for biosimilars to introduce new indications or formulation changes, which could significantly impact their market competitiveness and accessibility.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
