Evolution of the EU Biosimilar Framework: Past and Future

Switching Reference Medicines to Biosimilars: A Systematic Literature Review of Clinical Outcomes

(2018) Hillel P. Cohen et al.   DRUGS

Identifiability of Biologicals in Adverse Drug Reaction Reports Received From European Clinical Practice

(2018) Niels S. Vermeer et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar

(2017) Seokkyun Kim et al.   mAbs

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

Möglichkeiten und Herausforderungen der Extrapolation bei Biosimilars

(2016) M. Weise et al.   ZEITSCHRIFT FUR GASTROENTEROLOGIE

BEYOND: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study of First-Line Carboplatin/Paclitaxel Plus Bevacizumab or Placebo in Chinese Patients With Advanced or Recurrent Nonsquamous Non–Small-Cell Lung Cancer

(2015) Caicun Zhou et al.   JOURNAL OF CLINICAL ONCOLOGY

Analysis of in vitro ADCC and clinical response to trastuzumab: possible relevance of FcγRIIIA/FcγRIIA gene polymorphisms and HER-2 expression levels on breast cancer cell lines

(2015) Silvia Boero et al.   Journal of Translational Medicine

Biosimilars: the science of extrapolation

(2014) M. Weise et al.   BLOOD

Biosimilars entering the clinic without animal studies

(2014) Leon AGJM van Aerts et al.   mAbs

Traceability of Biopharmaceuticals in Spontaneous Reporting Systems: A Cross-Sectional Study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance Databases

(2013) Niels S. Vermeer et al.   DRUG SAFETY

The State of the Art in the Development of Biosimilars

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

Randomized phase II study of first-line carboplatin-paclitaxel with or without bevacizumab in Japanese patients with advanced non-squamous non-small-cell lung cancer

(2012) Seiji Niho et al.   LUNG CANCER

High-mannose glycans on the Fc region of therapeutic IgG antibodies increase serum clearance in humans

(2011) A. M. Goetze et al.   GLYCOBIOLOGY

Acceptable changes in quality attributes of glycosylated biopharmaceuticals

(2011) Martin Schiestl et al.   NATURE BIOTECHNOLOGY