Merck’s list price for its newly launched biosimilar Renflexis (infliximab-abda) represents a 35% discount to originator biologic Remicade and undercuts a competing biosimilar by 20%.
Renflexis will be introduced in the U.S. with a wholesale acquisition cost (WAC) of $753.39, Merck said. A 100-mg dose of Remicade (infliximab, Janssen) had a WAC of $1,167.82 on Red Book July 24, while Inflectra (infliximab-dyyb, Celltrion/Pfizer) had a WAC of $946.28.
WACs do not include discounts that may be paid on the products.
Renflexis, approved by FDA on April 21 for all eligible indications, is the first medicine available in the U.S. under a global biosimilars development and commercialization agreement between Merck and Samsung Bioepis Co., Ltd.
The FDA approval of Renflexis (infliximab-abda) was based on Samsung Bioepis’ comprehensive data package, including analytical, nonclinical, and clinical pharmacokinetic, safety, and effectiveness data demonstrating that Renflexis is highly similar to Remicade in terms of safety, purity, and potency.
Renflexis is a tumor necrosis factor blocker approved in the U.S. for Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis in various patient populations.
The FDA approved the first Remicade biosimilar, Inflectra, on April 5, 2016,