Evolution of the EU Biosimilar Framework: Past and Future

por Wolff-Holz, Elena, Tiitso, Klara, Vleminckx, Camille, Weise, Martina
Publicado 2019

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

por Kurki, Pekka, Barry, Sean, Bourges, Ingrid, Tsantili, Panagiota, Wolff-Holz, Elena
Publicado 2021

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

por Vermeer, Niels S., Giezen, Thijs J., Zastavnik, Sofia, Wolff‐Holz, Elena, Hidalgo‐Simon, Ana
Publicado 2019

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

por Kurki, Pekka, Kang, Hye-Na, Ekman, Niklas, Knezevic, Ivana, Weise, Martina, Wolff-Holz, Elena
Publicado 2022

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

por Correia Pinheiro, Luis, Giezen, Thijs J., Wolff‐Holz, Elena, Weise, Martina, Laslop, Andrea, Hidalgo‐Simon, Ana
Publicado 2021

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

por Kirsch-Stefan, Nadine, Guillen, Elena, Ekman, Niklas, Barry, Sean, Knippel, Verena, Killalea, Sheila, Weise, Martina, Wolff-Holz, Elena
Publicado 2023

Preparing for the incoming wave of biosimilars in oncology

por Wolff-Holz, Elena, Garcia Burgos, Juan, Giuliani, Rosa, Befrits, Gustaf, de Munter, Johan, Avedano, Luisa, Aitken, Murray, Gonzalez-Quevedo, Rosa, Vyas, Malvika, de Vries, Elisabeth G E, Tabernero, Josep
Publicado 2018