E Wolff-Holz

Affiliations

Paul-Ehrlich-Institut, Germany.

Publications (9)

Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union's Database of Reports of Suspected Adverse Drug Reactions.

Clinical pharmacology and therapeutics

Avec: Luis Correia Pinheiro , Thijs J Giezen , Elena Wolff-Holz , Martina Weise , Andrea Laslop , Ana Hidalgo-Simon

Evolution of the EU Biosimilar Framework: Past and Future.

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

Avec: Elena Wolff-Holz , Klara Tiitso , Camille Vleminckx , Martina Weise

WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June - 2 July 2021.

Biologicals : journal of the International Association of Biological Standardization

Avec: Meenu Wadhwa , Hye-Na Kang , Robin Thorpe , Ivana Knezevic , Auteur inconnu , P Aprea , M-C Bielsky , N Ekman , H-K Heim , J Joung , P Kurki , E Lacana , C Njue , E Nkansah , M Savkina , R Thorpe , T Yamaguchi , M Wadhwa , J Wang , M Weise , E Wolff-Holz , Auteur inconnu , Auteur inconnu , Auteur inconnu , Auteur inconnu , Auteur inconnu , Auteur inconnu , Auteur inconnu , Auteur inconnu

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

Clinical pharmacology and therapeutics

Avec: Niels S Vermeer , Thijs J Giezen , Sofia Zastavnik , Elena Wolff-Holz , Ana Hidalgo-Simon

Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective.

Drugs

Avec: Pekka Kurki , Sean Barry , Ingrid Bourges , Panagiota Tsantili , Elena Wolff-Holz

Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

Avec: Nadine Kirsch-Stefan , Elena Guillen , Niklas Ekman , Sean Barry , Verena Knippel , Sheila Killalea , Martina Weise , Elena Wolff-Holz

[Biosimilars in the European Union: current situation and challenges].

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz

Avec: Elena Wolff-Holz , Martina Weise

Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience.

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

Avec: Pekka Kurki , Hye-Na Kang , Niklas Ekman , Ivana Knezevic , Martina Weise , Elena Wolff-Holz

A Data Driven Approach to Support Tailored Clinical Programs for Biosimilar Monoclonal Antibodies.

Clinical pharmacology and therapeutics

Avec: Elena Guillen , Niklas Ekman , Sean Barry , Martina Weise , Elena Wolff-Holz

Réseau de co-auteurs

None None 9 collaborations

Elena Wolff-Holz 8 collaborations

Martina Weise 6 collaborations

Sean Barry 3 collaborations

Niklas Ekman 3 collaborations

Thijs J Giezen 2 collaborations

Ana Hidalgo-Simon 2 collaborations

Hye-Na Kang 2 collaborations

Ivana Knezevic 2 collaborations

Pekka Kurki 2 collaborations

Elena Guillen 2 collaborations

Luis Correia Pinheiro 1 collaboration

Andrea Laslop 1 collaboration

Klara Tiitso 1 collaboration

Camille Vleminckx 1 collaboration

Meenu Wadhwa 1 collaboration

Robin Thorpe 1 collaboration

P Aprea 1 collaboration

M-C Bielsky 1 collaboration

N Ekman 1 collaboration

H-K Heim 1 collaboration

J Joung 1 collaboration

P Kurki 1 collaboration

E Lacana 1 collaboration

C Njue 1 collaboration

E Nkansah 1 collaboration

M Savkina 1 collaboration

R Thorpe 1 collaboration

T Yamaguchi 1 collaboration

M Wadhwa 1 collaboration

J Wang 1 collaboration

M Weise 1 collaboration

Niels S Vermeer 1 collaboration

Sofia Zastavnik 1 collaboration

Ingrid Bourges 1 collaboration

Panagiota Tsantili 1 collaboration

Nadine Kirsch-Stefan 1 collaboration

Verena Knippel 1 collaboration

Sheila Killalea 1 collaboration