Interchangeability of biosimilar and biological reference product: updated regulatory positions and pre- and post-marketing evidence

Is there a reason for concern or is it just hype? – A systematic literature review of the clinical consequences of switching from originator biologics to biosimilars

(2017) András Inotai et al.   EXPERT OPINION ON BIOLOGICAL THERAPY

Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial

(2017) Kristin K Jørgensen et al.   LANCET

Ten years of clinical experience with biosimilar human growth hormone: a review of safety data

(2017) Maria Victoria Borrás Pérez et al.   Drug Design Development and Therapy

A review of the literature analyzing benefits and concerns of infliximab biosimilar CT-P13 for the treatment of rheumatologic diseases: focus on interchangeability

(2017) Andrea Becciolini et al.   Drug Design Development and Therapy

Switching Between Reference Biologics and Biosimilars for the Treatment of Rheumatology, Gastroenterology, and Dermatology Inflammatory Conditions: Considerations for the Clinician

(2017) Robert Moots et al.   Current Rheumatology Reports

Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study

(2016) Won Park et al.   ANNALS OF THE RHEUMATIC DISEASES

Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study

(2016) Dae Hyun Yoo et al.   ANNALS OF THE RHEUMATIC DISEASES

Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents

(2016) Balázs Vezér et al.   CURRENT MEDICAL RESEARCH AND OPINION

The challenging definition of naïve patient for biological drug use

(2015) Martina Biggioggero et al.   AUTOIMMUNITY REVIEWS

Recommendations on how to ensure the safety and effectiveness of biosimilars in Latin America: a point of view

(2015) Carlos Pineda et al.   CLINICAL RHEUMATOLOGY

Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data

(2015) Elena Nikiphorou et al.   EXPERT OPINION ON BIOLOGICAL THERAPY

Switching Between Infliximab Originator and Biosimilar in Paediatric Patients with Inflammatory Bowel Disease. Preliminary Observations

(2015) J. Sieczkowska et al.   Journal of Crohns & Colitis

Japanese regulatory authority's perspective on biosimilars

(2015) Sumimasa Nagai et al.   LANCET ONCOLOGY

Patients' preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study

(2014) X. Pivot et al.   ANNALS OF ONCOLOGY

Regulatory and clinical considerations for biosimilar oncology drugs

(2014) Charles L Bennett et al.   LANCET ONCOLOGY

Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic inflammatory diseases: a real issue, a clinical perspective

(2012) Fabien B Vincent et al.   ANNALS OF THE RHEUMATIC DISEASES

A population-based study comparing biosimilar versus originator erythropoiesis-stimulating agent consumption in 6,117 patients with renal anaemia

(2012) Franziska Hörbrand et al.   EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

The safety of switching between therapeutic proteins

(2012) Hans C Ebbers et al.   EXPERT OPINION ON BIOLOGICAL THERAPY

Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development

(2012) Xiao-Yan Cai et al.   Bioanalysis

Switching epoetin alfa and epoetin zeta in patients with Renal Anemia on Dialysis: Posthoc analysis

(2010) Andrzej Więcek et al.   ADVANCES IN THERAPY

Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor α inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial

(2009) Josef S Smolen et al.   LANCET

Individual medicine in inflammatory bowel disease: Monitoring bioavailability, pharmacokinetics and immunogenicity of anti-tumour necrosis factor-alpha antibodies

(2009) Klaus Bendtzen et al.   SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY

Immunogenicity of anti-tumor necrosis factor antibodies—toward improved methods of anti-antibody measurement

(2008) Lucien Aarden et al.   CURRENT OPINION IN IMMUNOLOGY

Clinical immunotoxicity of therapeutic proteins

(2008) Jacques Descotes et al.   Expert Opinion on Drug Metabolism & Toxicology