Incorporating historical information in biosimilar trials: Challenges and a hybrid Bayesian-frequentist approach

Author:

Mielke Johanna1ORCID,Schmidli Heinz1,Jones Byron1ORCID

Affiliation:

1. Statistical Methodology; Novartis Pharma AG 4002 Basel Switzerland

Funder

Staatssekretariat für Bildung, Forschung und Innovation

H2020 Marie Skłodowska-Curie Actions

Publisher

Wiley

Subject

Statistics, Probability and Uncertainty,General Medicine,Statistics and Probability

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3. Applications of the Bayesian prior information to evaluation of equivalence of similar biological medicinal products;Chiu;Journal of Biopharmaceutical Statistics,2014

4. CHMP 2009 Zarzio: EPAR - public assessment report http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000917/WC500046528.pdf

5. CHMP 2017 Amgevita: EPAR - public assessment report http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public%_assessment_report/human/004212/WC500225231.pdf

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