The study investigators noted that the number of individual case safety reports related to infliximab biosimilars increased directly after the marketing availability of the medicines in Italy, which can be interpreted as a result of more patients having access to infliximab therapy.
Infliximab can be linked with adverse events (AEs) such as infusion reactions, hypersensitivity, and immunogenicity. Recently, Italian researchers sought to assess the scope of preventable AEs found in individual case safety reports (ICSRs) for patients taking biosimilar infliximab versus those taking originator infliximab, and reported their findings in a recent study.
From October 2015 to October 2017, the researchers identified 459 ICSRs that reported infliximab as the suspected drug across the spontaneous reporting systems in Italy. During this period, 81,906 vials of infliximab were distributed, accounting for a reporting rate of 6 ICSRs per 1000 vials.
For both the originator and biosimilars, ICSRs were reported. In total, 222 ICSRs were reported for the originator biosimilar, Remicade, and 237 ICSRs were reported for the infliximab biosimilar CT-P13 (Remsima, Inflectra). Patients who experienced an adverse reaction to infliximab, both originator or biosimilars, had a mean age of 48.0 years (±15.5 years), and 54.5% were female.
More than 60% of patients who experienced an AE with infliximab were concomitantly receiving at least 1 other medication, and more than 80% of those patients had at least 1 comorbidity, including cardiac disorders, dyslipidemia, and acute or chronic infections. In terms of preventable cases of AEs, researchers identified 34 cases out of 459 (7.41%) that were considered to be preventable. For these cases, the detected critical criteria were mainly related to “documented hypersensitivity to administered drug or drug class,” “inappropriate prescription for patient’s underlying medical condition,” and “incorrect dose.”
The study investigators noted that, as expected, the number of ICSRs related to infliximab biosimilars increased directly after the marketing availability of the medicines in Italy, which can be interpreted as a result of more patients having access to infliximab therapy. The researchers also indicated that a direct correlation between the increased attention that all biosimilars have received from both clinicians and patients, as well as the increased reporting of AEs induced by the availability of biosimilar infliximab, could not be excluded as possibilities.
Overall, said the authors, no new safety issues emerged for the biosimilar infliximab or the originator product. “Considering the potential advantages offered by the increase in biosimilar utilization in clinical practice, both for patients and healthcare systems, we believe that the use of biosimilars, including those of infliximab, should be undoubtedly supported in clinical practice.”
Reference
Scavone C, Sessa M, Clementi E, et al. Real world data on the utilization pattern and safety profile of infliximab originator versus biosimilars in Italy: a multiregional study. BioDrugs. 2018;32(6):607-617. doi: 10.1007/s40259-018-0313-2.
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.
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?
Patients With IBD Maintain Therapy 2 Years Post Switching to Infliximab Biosimilar
March 23rd 2025People with inflammatory bowel disease (IBD) who switched to the infliximab biosimilar CT-P13 had higher treatment persistence (84% and 91%) than those new to infliximab (66% and 53%), with no new safety concerns.
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.
How Vertical Integration Drives Innovation and Access in Biosimilars
December 27th 2024Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.
Empowering Vulnerable Populations: The Path to Equitable Biologic Therapy Access
December 22nd 2024Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discusses strategies to improve equitable access to biologic therapies, including tiered formularies, income-based cost sharing, patient assistance programs, and fostering payer partnerships.