Approval of the first biosimilar antibodies in Europe

Rapid comparison of a candidate biosimilar to an innovator monoclonal antibody with advanced liquid chromatography and mass spectrometry technologies

(2014) Hongwei Xie et al.   mAbs

Physicochemical and Functional Comparability Between the Proposed Biosimilar Rituximab GP2013 and Originator Rituximab

(2013) Jan Visser et al.   BIODRUGS

The Continuum of Comparability Extends to Biosimilarity: How Much Is Enough and What Clinical Data Are Necessary?

(2013) M McCamish et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

A global comparability approach for biosimilar monoclonal antibodies using LC–tandem MS based proteomics

(2013) Shun-Li Chen et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Rapid and multi-level characterization of trastuzumab using sheathless capillary electrophoresis-tandem mass spectrometry

(2013) Rabah Gahoual et al.   mAbs

8thAnnual European Antibody Congress 2012

(2013) Alain Beck et al.   mAbs

Correct primary structure assessment and extensive glyco-profiling of cetuximab by a combination of intact, middle-up, middle-down and bottom-up ESI and MALDI mass spectrometry techniques

(2013) Daniel Ayoub et al.   mAbs

Analytical characterization of biosimilar antibodies and Fc-fusion proteins

(2013) Alain Beck et al.   TRAC-TRENDS IN ANALYTICAL CHEMISTRY

Quantitative Structural Characterization of Local N-Glycan Microheterogeneity in Therapeutic Antibodies by Energy-Resolved Oxonium Ion Monitoring

(2012) Atsuhiko Toyama et al.   ANALYTICAL CHEMISTRY

Characterization of Therapeutic Antibodies and Related Products

(2012) Alain Beck et al.   ANALYTICAL CHEMISTRY

Biosimilar, Biobetter, and Next Generation Antibody Characterization by Mass Spectrometry

(2012) Alain Beck et al.   ANALYTICAL CHEMISTRY

Biosimilars: what clinicians should know

(2012) M. Weise et al.   BLOOD

The State of the Art in the Development of Biosimilars

(2012) Mark McCamish et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Analytical aspects of biosimilarity issues of protein drugs

(2012) Zsuzsanna Kálmán-Szekeres et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

An innovative approach for the characterization of the isoforms of a monoclonal antibody product

(2012) Shanmuuga Sundaram et al.   mAbs

Characterization and comparison of commercially available TNF receptor 2-Fc fusion protein products

(2012) Qingqiao Tan et al.   mAbs

Setting the stage for biosimilar monoclonal antibodies

(2012) Christian K Schneider et al.   NATURE BIOTECHNOLOGY

Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars

(2012) Steven A. Berkowitz et al.   NATURE REVIEWS DRUG DISCOVERY

The rise of the biosimilar

(2012) Mark McCamish et al.   Expert Review of Clinical Pharmacology

Worldwide experience with biosimilar development

(2011) Mark McCamish et al.   mAbs

Biosimilar, biobetter and next generation therapeutic antibodies

(2011) Alain Beck   mAbs

Therapeutic Fc-fusion proteins and peptides as successful alternatives to antibodies

(2011) Alain Beck et al.   mAbs

Acceptable changes in quality attributes of glycosylated biopharmaceuticals

(2011) Martin Schiestl et al.   NATURE BIOTECHNOLOGY

Biosimilars—why terminology matters

(2011) Martina Weise et al.   NATURE BIOTECHNOLOGY

European Medicines Agency workshop on biosimilar monoclonal antibodies

(2010) Janice M. Reichert et al.   mAbs

Electrospray ionization quadrupole ion-mobility time-of-flight mass spectrometry as a tool to distinguish the lot-to-lot heterogeneity in N-glycosylation profile of the therapeutic monoclonal antibody trastuzumab

(2009) Carola W. N. Damen et al.   JOURNAL OF THE AMERICAN SOCIETY FOR MASS SPECTROMETRY

Toward biosimilar monoclonal antibodies

(2008) Christian K Schneider et al.   NATURE BIOTECHNOLOGY