Evolving Biosimilar Clinical Requirements: A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators.

Louise C DruedahlSofia Kälvemark SporrongMarco van de WeertMarie Louise De BruinHans HooglandTimo MinssenAnna Birna Almarsdóttir

Published in: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy (2021)

The main findings are that biosimilar clinical comparability trial requirements are likely to change in the near future. Clarity is needed on how to ensure adequate correlation between physicochemical data, pharmacokinetic/pharmacodynamic studies, and the drugs' performance in the clinic, as well as how to continue sufficient immunogenicity assessment. Obtaining this clarity can facilitate regulatory assessment of the next biosimilars.

Keyphrases

primary care
electronic health record
quality improvement
randomized controlled trial
big data
machine learning
drug administration