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Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
|
October 9, 2020
[Biosimilars in the European Union: current situation and challenges]
Elena Wolff-Holz, Martina Weise
Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
|
September 22, 2019
Evolution of the EU Biosimilar Framework: Past and Future
Elena Wolff-Holz, Klara Tiitso, Camille Vleminckx, et al.
Clinical Pharmacology and Therapeutics
|
December 22, 2022
A Data Driven Approach to Support Tailored Clinical Programs for Biosimilar Monoclonal Antibodies
Elena Guillen, Niklas Ekman, Sean Barry, et al.
Drugs
|
October 1, 2021
Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective
Pekka Kurki, Sean Barry, Ingrid Bourges, et al.
Blood
|
October 10, 2014
Biosimilars: the science of extrapolation
Martina Weise, Pekka Kurki, Elena Wolff-Holz, et al.
Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
|
January 26, 2017
Interchangeability of Biosimilars: A European Perspective
Pekka Kurki, Leon van Aerts, Elena Wolff-Holz, et al.
Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
|
May 21, 2022
Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience
Pekka Kurki, Hye-Na Kang, Niklas Ekman, et al.
Clinical Pharmacology and Therapeutics
|
November 22, 2018
Identifiability of Biologicals in Adverse Drug Reaction Reports Received From European Clinical Practice
Niels S Vermeer, Thijs J Giezen, Sofia Zastavnik, et al.
Clinical Pharmacology and Therapeutics
|
September 2, 2021
Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union's Database of Reports of Suspected Adverse Drug Reactions
Luis Correia Pinheiro, Thijs J Giezen, Elena Wolff-Holz, et al.
Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
|
July 17, 2025
Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study
Martin Schiestl, Nivedita Roy, Michael Trieb, et al.
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Search research articles
Search
Showing results (1-10 of 17) with videos related to
Sort By:
Page
of 2
Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
|
October 9, 2020
[Biosimilars in the European Union: current situation and challenges]
Elena Wolff-Holz, Martina Weise
Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
|
September 22, 2019
Evolution of the EU Biosimilar Framework: Past and Future
Elena Wolff-Holz, Klara Tiitso, Camille Vleminckx, et al.
Clinical Pharmacology and Therapeutics
|
December 22, 2022
A Data Driven Approach to Support Tailored Clinical Programs for Biosimilar Monoclonal Antibodies
Elena Guillen, Niklas Ekman, Sean Barry, et al.
Drugs
|
October 1, 2021
Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective
Pekka Kurki, Sean Barry, Ingrid Bourges, et al.
Blood
|
October 10, 2014
Biosimilars: the science of extrapolation
Martina Weise, Pekka Kurki, Elena Wolff-Holz, et al.
Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
|
January 26, 2017
Interchangeability of Biosimilars: A European Perspective
Pekka Kurki, Leon van Aerts, Elena Wolff-Holz, et al.
Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
|
May 21, 2022
Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience
Pekka Kurki, Hye-Na Kang, Niklas Ekman, et al.
Clinical Pharmacology and Therapeutics
|
November 22, 2018
Identifiability of Biologicals in Adverse Drug Reaction Reports Received From European Clinical Practice
Niels S Vermeer, Thijs J Giezen, Sofia Zastavnik, et al.
Clinical Pharmacology and Therapeutics
|
September 2, 2021
Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union's Database of Reports of Suspected Adverse Drug Reactions
Luis Correia Pinheiro, Thijs J Giezen, Elena Wolff-Holz, et al.
Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
|
July 17, 2025
Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study
Martin Schiestl, Nivedita Roy, Michael Trieb, et al.
Page
of 2