Keyword

biosimilarity

Description: Biosimilarity is the degree to which a biological medicine matches an approved reference product in quality, safety, and efficacy.

Primary topic: Biosimilars and Bioanalytical Methods (75%)

OpenAlex ID: keywords/biosimilarity

Bioequivalence and the immunogenicity of biopharmaceuticals

2002 · Huub Schellekens · Nature Reviews Drug Discovery · 535

Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians

2016 · Hillel Cohen, Donna Beydoun, et al. · Advances in Therapy · 208

PDF

Interchangeability of Biosimilars: A European Perspective

2017 · Pekka Kurki, Leon van Aerts, et al. · BioDrugs · 189

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

2017 · Seokkyun Kim, Jinsu Song, et al. · mAbs · 140

PDF

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

2016 · Balázs Vezér, Zsuzsanna Buzás, et al. · Current Medical Research and Opinion · 113

PDF

2019 · Josef S Smolen, Joao Goncalves, et al. · RMD Open · 102

Development of a new G-CSF product based on biosimilarity assessment

2009 · P. Gascon, U. Fuhr, et al. · Annals of Oncology · 90

PDF

Analytical and functional similarity of Amgen biosimilar ABP 215 to bevacizumab

2018 · Neungseon Seo, Alla Polozova, et al. · mAbs · 86

Mitochondrial encephalocardio-myopathy with early neonatal onset due to TMEM70 mutation

2010 · T. Honzik, M. Tesarova, et al. · Archives of Disease in Childhood · 79

PDF

The arrival of biosimilar monoclonal antibodies in oncology: clinical studies for trastuzumab biosimilars

2019 · Liese Barbier, Paul Declerck, et al. · British Journal of Cancer · 72

PDF

The role of mass spectrometry in the characterization of biologic protein products

2018 · Deepali Rathore, Anneliese Faustino, et al. · Expert Review of Proteomics · 72

A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final safety, immunogenicity and survival results

2018 · X. Pivot, I. Bondarenko, et al. · European Journal of Cancer · 70

2014 · Michael S Epstein, Eli D Ehrenpreis, et al. · The American Journal of Gastroenterology · 64

A prospective, randomized, double‐blind, multicentre, parallel‐group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia; ZRC ‐3197) and adalimumab (Humira) in patients with rheumatoid arthritis

2015 · Rajendrakumar H. Jani, Rajiv Gupta, et al. · International Journal of Rheumatic Diseases · 62

PDF

Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity

2020 · Tom W. J. Huizinga, Yoshifumi Torii, et al. · Rheumatology and Therapy · 56

PDF

Biopharmaceuticals for rheumatic diseases in Latin America, Europe, Russia, and India: Innovators, biosimilars, and intended copies

2014 · Gilberto Castañeda-Hernández, Zoltan Szekanecz, et al. · Joint Bone Spine · 54

2017 · Karthik Pisupati, Alexander Benet, et al. · mAbs · 53

PDF

Glycan analysis for protein therapeutics

2019 · Xiangkun Yang, Michael G. Bartlett · Journal of Chromatography B · 51

Demonstration of Functional Similarity of Proposed Biosimilar ABP 501 to Adalimumab

2016 · Jyoti Velayudhan, Yuh-feng Chen, et al. · BioDrugs · 51

PDF

Evaluation of similar quality attribute characteristics in SB5 and reference product of adalimumab

2018 · Nayoung Lee, JongAh Joanne Lee, et al. · mAbs · 50

PDF

2015 · Paul Declerck, Mourad Farouk-Rezk, et al. · Pharmaceutical Research · 50

2017 · Ira Jacobs, Reginald Ewesuedo, et al. · BioDrugs · 49

PDF

2016 · Ewa Olech · Seminars in Arthritis and Rheumatism · 48

Single, very low rituximab doses in healthy volunteers - a pilot and a randomized trial: implications for dosing and biosimilarity testing

2018 · Christian Schoergenhofer, Michael Schwameis, et al. · Scientific Reports · 47

PDF

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

2013 · M McCamish, G Woollett · Clinical Pharmacology & Therapeutics · 46

PDF

Works count: 526

Citation count: 5,735