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Introduction: As of May 2023, 19 and 18 biosimilars have been approved for the treatment of rheumatoid arthritis (RA) by the European Medicines Agency (EMA) and United States Food and Drug Administration (US FDA) respectively., Area Covered: Pharmacokinetic results of phase 1 studies of approved biosimilars were reviewed by systematic literature search. The impact of immunogenicity on the pharmacokinetic data and clinical response was assessed, and the potential benefit of monitoring serum concentrations of biologic drugs is discussed. The advantage of subcutaneous CT-P13 (an infliximab biosimilar) in clinical practice is reviewed., Expert Opinion: Biosimilars are approved based on the totality of evidence including comparable physiochemical properties, PK / PD profiles, and clinical efficacy and safety to the originator. To utilize biosimilars more effectively, physicians should be aware of the utility of combination DMARD therapy to reduce immunogenicity and maintain efficacy and PK profile. PK monitoring, however, is not currently recommended in clinical practice. CT-P13 subcutaneous (SC) is the first SC infliximab used for treatment of RA patients. Based on data from clinical studies and the real world, SC-infliximab is an attractive therapeutic option compared to IV formulations of infliximab based on its efficacy, pharmacokinetics, patient-reported outcomes, and safety profile.

Background: Several ultrasound (US)-based risk stratification systems have been increasingly used for the optimal management of thyroid nodules. However, there are considerable discrepancies across these systems. This study aimed to summarize and compare the category-based diagnostic performance in the detection of thyroid cancer of different US-based risk stratification systems from four societies: the American College of Radiology-Thyroid Imaging Reporting and Data System (ACR-TIRADS), the American Thyroid Association (ATA), the Korean Thyroid Association/Korean Society of Thyroid Radiology (KTA/KSThR; K-TIRADS), and the European Thyroid Association (EU-TIRADS). Methods: MEDLINE/PubMed and EMBASE databases were searched to identify original articles investigating the category-based diagnostic performance according to at least one of the following guidelines: ACR-TIRADS, ATA, K-TIRADS, and EU-TIRADS. Pooled sensitivity and specificity were calculated using a bivariate random-effects model. A subgroup analysis on nodules of 1 cm or larger and a meta-regression analysis to identify factors associated with the diagnostic performance were performed. Results: A total of 29 articles including 33,748 thyroid nodules met the eligibility criteria and were included in the analysis. For ACR-TIRADS, the pooled sensitivity and specificity were, respectively, 66% and 91% for category 5 and 95% and 55% for category 4 or 5. For ATA, the pooled sensitivity and specificity were, respectively, 74% and 88% for category 5 and 91% and 64% for category 4 or 5. For K-TIRADS, the pooled sensitivity and specificity were, respectively, 55% and 95% for category 5 and 89% and 64% for category 4 or 5. For EU-TIRADS, the pooled sensitivity and specificity were, respectively, 82% and 90% for category 5 and 96% and 52% for category 4 or 5. Study location, proportion of female patients and malignant nodules, and study design were associated with study heterogeneity. Conclusions: The overall diagnostic performance of the four US-based risk stratification systems was comparable.

Objective: To evaluate the efficacy and safety of CT-P10, a rituximab biosimilar after a single switch, during a multinational, randomized, double-blind Phase 3 trial involving patients with RA., Methods: Patients received 48 weeks' treatment with CT-P10 or United States- or European Union-sourced reference rituximab (US-RTX and EU-RTX, respectively). Patients entering the extension period (weeks 48-72) remained on CT-P10 (CT-P10/CT-P10; n = 122) or US-RTX (US-RTX/US-RTX; n = 64), or switched to CT-P10 from US-RTX (US-RTX/CT-P10; n = 62) or EU-RTX (EU-RTX/CT-P10; n = 47) for an additional course. Efficacy endpoints included Disease Activity Score using 28 joints (DAS28), American College of Rheumatology (ACR) response rates, and quality of life-related parameters. Pharmacodynamics, immunogenicity and safety were also assessed., Results: At week 72, similar improvements were observed by disease activity parameters including DAS28 and ACR response rate in the four extension period treatment groups. Quality of life improvements at week 72 vs baseline were similarly shown during the extension period in all groups. Newly developed anti-drug antibodies were detected in two patients following study drug infusion in the extension period. Similar pharmacodynamic and safety profiles were observed across groups., Conclusion: Long-term use of CT-P10 up to 72 weeks was effective and well tolerated. Furthermore, switching from reference rituximab to CT-P10 in RA was well tolerated and did not result in any clinically meaningful differences in terms of efficacy, pharmacodynamics, immunogenicity and safety., Trail Registration: ClinicalTrials.gov, http://clinicaltrials.gov, NCT02149121., (© The Author(s) 2019. Published by Oxford University Press on behalf of the British Society for Rheumatology.)