What Biosimilar Development: Comparability Exercise, Quality Comparability, Non-Clinical Studies, Clinical PK/PD Studies, Efficacy/Safety and Immunogenicity Assessment requires
This guideline outlines the scientific principles for demonstrating biosimilarity between a proposed biosimilar and its reference biological medicinal product through a stepwise comparability…
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Pillar: Pharmaceuticals & Life Sciences · Authority: European Medicines Agency (EMA) · Version: 1.0.1 · Last updated:
Primary source: https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines
SHA-256 integrity: 2da340281731bd62e8317634599a73dd38cdc05fc8f2ae1d14bf6df2d6fafc37
Primary Citations — 5 traced to source
- Scientific guidelines | European Medicines Agency (EMA) - EMA strongly encourages applicants and marketing authorisation holders to follow the guidelines featured on this page.
- Scientific guidelines | European Medicines Agency (EMA) - Applicants need to justify deviations from guidelines fully in their applications at the time of submission.
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