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Sigrid Balser
Observed names:
Balser, Sigrid,
S Balser,
S. Balser,
Sigrid E. Balser
Observed institutions:
Boehringer Ingelheim (Germany),
University of Cologne,
Hexal (Germany),
University Hospital Cologne,
Sandoz Group AG (Switzerland),
Sandoz (Japan)
show all 6
ORCID:
0000-0002-9548-1550
Observed ORCID:
0000-0002-9548-1550
OpenAlex ID:
A5021481344
Development of a new G-CSF product based on biosimilarity assessment
2009
·
P. Gascon
, U. Fuhr
, et al.
·
Annals of Oncology
·
90
PDF
Population Modeling of Filgrastim PK‐PD in Healthy Adults Following Intravenous and Subcutaneous Administrations
2010
·
Wojciech Krzyzanski
, Pawel Wiczling
, et al.
·
The Journal of Clinical Pharmacology
·
50
Safety and efficacy of BI 695501 versus adalimumab reference product in patients with advanced Crohn's disease (VOLTAIRE-CD): a multicentre, randomised, double-blind, phase 3 trial
2021
·
Stephen Hanauer
, Bernd Liedert
, et al.
·
The Lancet. Gastroenterology & hepatology
·
43
Population Pharmacokinetic and Pharmacodynamic Model‐Based Comparability Assessment of a Recombinant Human Epoetin Alfa and the Biosimilar HX575
2011
·
Xiaoyu Yan
, Philip J. Lowe
, et al.
·
The Journal of Clinical Pharmacology
·
38
Totality of the evidence at work: The first U.S. biosimilar
2015
·
J. Holzmann
, S. Balser
, et al.
·
Expert Opinion on Biological Therapy
·
36
PDF
Population Pharmacokinetic Modelling of Filgrastim in Healthy Adults following Intravenous and Subcutaneous Administrations
2009
·
Pawel Wiczling
, Philip Lowe
, et al.
·
Clinical Pharmacokinetics
·
27
Long-term safety and efficacy of the recombinant human growth hormone omnitrope® in the treatment of Spanish growth hormone deficient children: Results of a phase III study
2011
·
J. López-Siguero
, V. Borrás Pérez
, et al.
·
Advances in Therapy
·
26
Similar efficacy, safety, and immunogenicity of the biosimilar BI 695501 and adalimumab reference product in patients with moderate-to-severe chronic plaque psoriasis: results from the randomized Phase III VOLTAIRE-PSO study
2020
·
Alan Menter
, Petr Arenberger
, et al.
·
Expert Opinion on Biological Therapy
·
23
PDF
Bioequivalence between novel ready-to-use liquid formulations of the recombinant human GH Omnitrope and the original lyophilized formulations for reconstitution of Omnitrope and Genotropin
2010
·
Uwe Fuhr
, Daniel Tuculanu
, et al.
·
European Journal of Endocrinology
·
23
Pharmacokinetic Similarity of Biologics: Analysis Using Nonlinear Mixed-Effects Modeling
2011
·
A Dubois
, S Gsteiger
, et al.
·
Clinical Pharmacology & Therapeutics
·
20
Effect of switching recombinant human growth hormone: Comparative analysis of phase 3 clinical data
2011
·
Tomasz Romer
, Markus Zabransky
, et al.
·
Biologics in Therapy
·
20
PDF
Establishment and validation of an ex vivo human cervical tissue model for local delivery studies
2007
·
Christian Hiller
, Udo Bock
, et al.
·
European Journal of Pharmaceutics and Biopharmaceutics
·
11
Phase 3 Trial of BI 695502 Plus Chemotherapy Versus Bevacizumab Reference Product Plus Chemotherapy in Patients With Advanced Nonsquamous NSCLC
2021
·
Edward S. Kim
, Sigrid Balser
, et al.
·
JTO Clinical and Research Reports
·
10
PDF
A Randomised, Double-Blind Trial to Compare the Efficacy, Safety, and Immunogenicity of the Biosimilar Ustekinumab FYB202 with Reference Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis
2025
·
Kim Papp
, Sigrid Balser
, et al.
·
Advances in Therapy
·
7
New Ustekinumab Biosimilar Candidate FYB202: Pharmacokinetic Equivalence Demonstrated in a Randomized, Double‐Blind, Parallel‐Group, Single‐Dose Trial in Healthy Subjects
2024
·
Sigrid Balser
, Katrin Nopora
, et al.
·
Clinical Pharmacology in Drug Development
·
7
PDF
13097 Biosimilar BI 695501 demonstrates clinical equivalence to adalimumab reference product in patients with moderate to severe chronic plaque psoriasis through 24 weeks
2020
·
Alan Menter
, Petr Arenberger
, et al.
·
Journal of the American Academy of Dermatology
·
4
Phase IIIb study of the bevacizumab biosimilar candidate BI 695502 plus mFOLFOX6 in metastatic colorectal cancer
2022
·
Tanios S Bekaii-Saab
, Sigrid Balser
, et al.
·
Colorectal Cancer
·
1
Tu1862 BI 695501 DEMONSTRATES SIMILAR EFFICACY AND COMPARABLE SAFETY TO ADALIMUMAB REFERENCE PRODUCT IN PATIENTS WITH ACTIVE CROHN'S DISEASE: FINAL ANALYSIS OF THE PHASE III VOLTAIRE-CD STUDY
2020
·
Stephen B. Hanauer
, Stefan Schreiber
, et al.
·
Gastroenterology
·
1
P052 Biosimilar BI 695501 Demonstrates Non-Inferior Efficacy and Comparable Safety to Adalimumab Reference Product in Patients With Active Crohn's Disease
2019
·
Stephen Hanauer
, Stefan Schreiber
, et al.
·
The American Journal of Gastroenterology
·
1
From Reflection to Implementation: Tailored Clinical Development of a Pembrolizumab Biosimilar Candidate
2026
·
Björn Capsius
, Marija Pesic
, et al.
·
BioDrugs
PDF
Randomised, double-masked trial to compare the efficacy, safety and immunogenicity of the biosimilar aflibercept FYB203 with reference aflibercept in patients with neovascular age-related macular degeneration
2026
·
Sigrid Balser
, Björn Capsius
, et al.
·
BMJ Open Ophthalmology
PDF
Nachweis der Biosimilarität von Fresenius Kabi Ustekinumab (FK-Uste) zum Referenz-Ustekinumab – Entwicklung nach dem Prinzip der „Totality of Evidence“
2025
·
C Prinz
, L Rosemeyer
, et al.
·
Zeitschrift für Gastroenterologie
P0879 The totality of evidence for FYB202 – an EU-approved and US-licensed biosimilar to reference ustekinumab
2025
·
S Balser
, B Freudensprung
, et al.
·
Journal of Crohn s and Colitis
Similar efficacy, safety, and immunogenicity of the biosimilar BI 695501 and adalimumab reference product in patients with moderate-to-severe chronic plaque psoriasis: results from the randomized Phase III VOLTAIRE-PSO study
2020
·
Menter, Alan
, Arenberger, Petr
, et al.
·
Figshare
The Clinical Development of Biosimilar Drugs
2017
·
Mark McCamish
, Gillian Woollett
, et al.
·
CRC Press eBooks
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Works count:
27
Citation count:
438
H-index:
11
I10-index:
13
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