The road from development to approval: evaluating the body of evidence to confirm biosimilarity

The changing landscape of biosimilars in rheumatology

(2016) Thomas Dörner et al.   ANNALS OF THE RHEUMATIC DISEASES

Switching to biosimilar infliximab (CT-P13): Evidence of clinical safety, effectiveness and impact on public health

(2016) Jürgen Braun et al.   BIOLOGICALS

Tumour necrosis factor inhibition versus rituximab for patients with rheumatoid arthritis who require biological treatment (ORBIT): an open-label, randomised controlled, non-inferiority, trial

(2016) Duncan Porter et al.   LANCET

The Budget Impact of Biosimilar Infliximab (Remsima®) for the Treatment of Autoimmune Diseases in Five European Countries

(2015) Ashok Jha et al.   ADVANCES IN THERAPY

Step-down strategy of spacing TNF-blocker injections for established rheumatoid arthritis in remission: results of the multicentre non-inferiority randomised open-label controlled trial(STRASS: Spacing of TNF-blocker injections in Rheumatoid ArthritiS Study)

(2015) Bruno Fautrel et al.   ANNALS OF THE RHEUMATIC DISEASES

Key considerations in the preclinical development of biosimilars

(2015) Lynne A. Bui et al.   DRUG DISCOVERY TODAY

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

Biosimilarity Versus Manufacturing Change: Two Distinct Concepts

(2015) Paul Declerck et al.   PHARMACEUTICAL RESEARCH

Disease activity guided dose reduction and withdrawal of adalimumab or etanercept compared with usual care in rheumatoid arthritis: open label, randomised controlled, non-inferiority trial

(2015) N. van Herwaarden et al.   BMJ-British Medical Journal

Disease activity guided dose reduction and withdrawal of adalimumab or etanercept compared with usual care in rheumatoid arthritis: open label, randomised controlled, non-inferiority trial

(2015) N. van Herwaarden et al.   BMJ-British Medical Journal

Randomised controlled trial of Tumour necrosis factor inhibitors Against Combination Intensive Therapy with conventional disease-modifying antirheumatic drugs in established rheumatoid arthritis: the TACIT trial and associated systematic reviews

(2014) David L Scott et al.   HEALTH TECHNOLOGY ASSESSMENT

Characterization of golimumab, a human monoclonal antibody specific for human tumor necrosis factor α

(2014) David J. Shealy et al.   mAbs

Biosimilars entering the clinic without animal studies

(2014) Leon AGJM van Aerts et al.   mAbs

Biosimilar competition: lessons from Europe

(2014) Henry Grabowski et al.   NATURE REVIEWS DRUG DISCOVERY

Biosimilars 101: considerations for U.S. oncologists in clinical practice

(2014) Luis H. Camacho et al.   Cancer Medicine

Inequities in access to biologic and synthetic DMARDs across 46 European countries

(2013) Polina Putrik et al.   ANNALS OF THE RHEUMATIC DISEASES

Biologic therapy for autoimmune diseases: an update

(2013) Ziv Rosman et al.   BMC Medicine

Biosimilar monoclonal antibodies: a science-based regulatory challenge

(2013) Paul J Declerck   EXPERT OPINION ON BIOLOGICAL THERAPY

Maintenance, reduction, or withdrawal of etanercept after treatment with etanercept and methotrexate in patients with moderate rheumatoid arthritis (PRESERVE): a randomised controlled trial

(2013) Josef S Smolen et al.   LANCET

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

The role of biosimilars in the treatment of rheumatic diseases

(2012) Thomas Dörner et al.   ANNALS OF THE RHEUMATIC DISEASES

Biosimilars: what clinicians should know

(2012) M. Weise et al.   BLOOD

Biosimilar, biobetter and next generation therapeutic antibodies

(2011) Alain Beck   mAbs

Acceptable changes in quality attributes of glycosylated biopharmaceuticals

(2011) Martin Schiestl et al.   NATURE BIOTECHNOLOGY

Stability of IgG isotypes in serum

(2010) Ivan Correia   mAbs

Quality by Design applications in biosimilar pharmaceutical products

(2008) Ron S. Kenett et al.   ACCREDITATION AND QUALITY ASSURANCE