A recent case report, published in the European Journal of Rheumatology, showed that switching to biosimilar infliximab resulted in a rapid loss of efficacy in 3 patients with Behçet’s disease (BD), a chronic, relapsing, systemic vasculitis.
A recent case report, published in the European Journal of Rheumatology, showed that switching to biosimilar infliximab resulted in a rapid loss of efficacy in 3 patients with Behçet’s disease (BD), a chronic, relapsing, systemic vasculitis.
Severe clinical manifestations of BD include eye, intestinal, and neurological inflammatory involvement that may be refractory to treatment with corticosteroids or immunosuppressive drugs, and may warrant treatment with infliximab.
When biosimilar infliximab CT-P13 (Inflectra, Remsima) was approved in the European Union, it offered a lower-cost option for treating patients with BD, but in 3 cases observed by the Rheumatology Department of Prato, a referral center for rare rheumatic diseases in Italy, a non-medical switch to CT-P13 in patients’ local health clinics was associated with a relapse of BD.
Case 1
A 32-year-old man with BD who did not respond adequately to corticosteroids, methotrexate, and cyclosporine A was treated with reference infliximab at a dose of 5mg per kg at weeks 0, 2, 6, and every 8 weeks thereafter. His symptoms subsided after the third infusion, and he achieved clinical remission (which was maintained on reference infliximab therapy). Two weeks after switching to CT-P13, the patient developed cutaneous vasculitis with papulopustulosis, oral and genital ulcers, and worsening of visual acuity. He required treatment with subcutaneous adalimumab to resolve the retinal vasculitis.
Case 2
A 40-year-old woman with BD who had bilateral posterior uveitis and cerebral vasculitis achieved stable disease remission with reference infliximab therapy at 5 mg per kg for 5 years. She was then switched to CT-P13 and experienced a loss of response after her third infusion. She experienced posterior uveitis, fever, headache, loss of balance, and cognitive impairment, among other symptoms. Treatment with intravenous methylprednisolone plus adalimumab was required to return the patient to clinical remission.
Case 3
A 26-year-old man with BD had neurological and intestinal involvement of BD that was refractory to treatment with methotrexate. Reference infliximab at a dose of 5 mg per kg allowed the patient to achieve complete disease remission that was maintained for the next 5 years. He was switched to CT-P13, and after the second infusion, oral aphthosis, papulopustulosis, and neurological and intestinal manifestations of BD recurred. Intravenous methylprednisolone and adalimumab were required to return the patient to complete remission over the next 2 months.
The case study’s authors state that, “In the absence of a valid explanation, we could only hypothesize that the rapid failure of [CT-P13] in our 3 patients might be related to the development of ADAs against [the biosimilar.]” While technical problems (such as improper storage or drug solution preparation issues) could be responsible for the loss of efficacy of CT-P13, the authors state that “Our experience with the 3 BD patients who were successfully treated with [reference infliximab] and who experienced recurrence...soon after switching to [CT-P13] appears to reinforce skepticism regarding the exchangeability and automatic substitution of reference [infliximab] with the biosimilar drug."
Etanercept Biosimilar Switch Shows Stable Outcomes and Disease Control in RA
May 13th 2025Patients with rheumatoid arthritis (RA) who switched from Enbrel (reference etanercept) to a biosimilar maintained remission, even after their dose was reduced, with no signs of worsening based on clinical scores, ultrasound scans, or lab tests, according to a new study.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.