Chapter-13 Regulations for the Development and Clinical Trials of Biosimilars
BOOK TITLE: Drug Discovery and Clinical Research
Author
1. Prakash Jai
2. Bhatia Amandeep
ISBN
9789352705771
DOI
10.5005/jp/books/18166_14
Edition
2/e
Publishing Year
2019
Pages
16
Author Affiliations
2.
Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Ghaziabad, Uttar Pradesh, India
Chapter keywords
Regulation,
clinical trial,
biosimilar,
biotherapeutics,
biotech drug,
biomedicine,
generic medicine,
clinical development,
European Union regulation,
European medicines agency,
EMA,
interchangeable product