Differentiating biosimilarity and comparability in biotherapeutics

NCCN Biosimilars White Paper: Regulatory, Scientific, and Patient Safety Perspectives

(2017) Andrew D. Zelenetz et al.   Journal of the National Comprehensive Cancer Network

Biosimilar: what it is not

(2015) Fernando de Mora   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Progress and Hurdles for Follow-on Biologics

(2015) Ameet Sarpatwari et al.   NEW ENGLAND JOURNAL OF MEDICINE

Biosimilarity Versus Manufacturing Change: Two Distinct Concepts

(2015) Paul Declerck et al.   PHARMACEUTICAL RESEARCH

FDA Approves First Biosimilar, Zarxio

(2015)   Cancer Discovery

Drift, Evolution, and Divergence in Biologics and Biosimilars Manufacturing

(2014) Sundar Ramanan et al.   BIODRUGS

Biosimilars to treat inflammatory arthritis: the challenge of proving identity

(2013) Jonathan Kay et al.   ANNALS OF THE RHEUMATIC DISEASES

A preliminary algorithm introducing immunogenicity assessment in the management of patients with RA receiving tumour necrosis factor inhibitor therapies

(2013) Sandra Garcês et al.   ANNALS OF THE RHEUMATIC DISEASES

Biosimilar monoclonal antibodies: a science-based regulatory challenge

(2013) Paul J Declerck   EXPERT OPINION ON BIOLOGICAL THERAPY

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

Comparability and biosimilarity: considerations for the healthcare provider

(2012) Jaymi F. Lee et al.   CURRENT MEDICAL RESEARCH AND OPINION

Worldwide experience with biosimilar development

(2011) Mark McCamish et al.   mAbs

Biosimilar, biobetter and next generation therapeutic antibodies

(2011) Alain Beck   mAbs

The New European Medicines Agency Guideline on the Investigation of Bioequivalence

(2010) José Augusto Guimarães Morais et al.   BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY

Biopharmaceutical benchmarks 2010

(2010) Gary Walsh   NATURE BIOTECHNOLOGY