Related Experiment Video

Updated: Feb 22, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

Published on: May 4, 2017

18.3K

Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and

Josef S Smolen1, Jung-Yoon Choe2, Nenad Prodanovic3

  • 1Division of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria.

Rheumatology (Oxford, England)
|September 29, 2017
PubMed
Abstract

Insights

SB2 demonstrated comparable efficacy, safety, and immunogenicity to infliximab (INF) in rheumatoid arthritis patients up to 54 weeks. Radiographic progression was similar between the SB2 biosimilar and INF, confirming long-term clinical similarity.

Area of Science:

  • Rheumatology
  • Immunology
  • Pharmacology

Background:

  • Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by joint inflammation.
  • Methotrexate (MTX) is a common treatment for RA, but some patients require additional therapies.
  • Biosimilars offer potential alternatives to reference biologics, requiring rigorous clinical evaluation.

Purpose of the Study:

  • To evaluate the long-term clinical similarity between SB2, a biosimilar to infliximab (INF), and INF in patients with moderate to severe RA.
  • To assess the efficacy, safety, immunogenicity, and structural joint damage progression up to 54 weeks.

Main Methods:

  • A phase III, double-blind, randomized, parallel-group, multicentre study.
  • 584 patients with RA were randomized to receive SB2 or INF (3 mg/kg, escalating up to 7.5 mg/kg).
  • Efficacy, safety, immunogenicity, and radiographic damage (modified total Sharp score) were assessed up to week 54.

Main Results:

  • Radiographic progression was comparable between SB2 and INF groups at 1 year (mean difference: 0.38 vs 0.37).
  • Efficacy endpoints (ACR responses, DAS, CDAI, SDAI) and safety profiles were similar up to week 54.
  • Incidence of adverse events and anti-drug antibodies were comparable, supporting consistent clinical similarity.

Conclusions:

  • SB2 maintained similar efficacy, safety, and immunogenicity compared to INF up to 54 weeks in RA patients.
  • The study confirms comparable radiographic progression at 1 year, supporting SB2 as a clinically similar biosimilar to INF.
Keywords:
FlixabiRemicadeRenflexisSharp scorebiosimilarinfliximabmonoclonal antibodyradiographic progressionrheumatoid arthritistumour necrosis factor blocker

More Related Videos

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety06:37

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety

Published on: September 15, 2023

1.2K
Comparison of Three Clinical Stereoscopic Methods for Measuring Binocular Visual Function During Amblyopic Treatment in Unilateral Amblyopia06:19

Comparison of Three Clinical Stereoscopic Methods for Measuring Binocular Visual Function During Amblyopic Treatment in Unilateral Amblyopia

Published on: September 27, 2024

577

Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
298
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
306
Bioequivalence: Overview01:16

Bioequivalence: Overview

Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
2.1K
Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF01:24

Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF

Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
610
Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
177
Bioequivalence Data: Statistical Interpretation01:16

Bioequivalence Data: Statistical Interpretation

Body:The statistical interpretation of bioequivalence data is a significant aspect of pharmaceutical research. Bioequivalence refers to the absence of any significant difference in the rate and extent to which the active ingredient in pharmaceutical products becomes available at the site of drug action when administered at the same molar dose under similar conditions. This helps determine if different drug products have similar absorption rates, ensuring their interchangeability.Statistical...
247