On the regulatory approval pathway of biosimilar products

• Main Authors: Wang, J, Chow, S.-C
• Other Authors: DUKE-NUS MEDICAL SCHOOL
• Format: Review
• Published: 2020
• Subjects: biological product; bioequivalence; biological activity; Canada; clinical evaluation; drug approval; drug efficacy; drug manufacture; drug purity; drug quality; drug research; drug safety; drug stability; European Medicines Agency; European Union; food and drug administration; government regulation; Japan; Korea; medical society; organization; pharmacodynamics; pharmacokinetics; physical chemistry; political participation; practice guideline; review; United States; world health organization
• Online Access: https://scholarbank.nus.edu.sg/handle/10635/180841
• Institution: National University of Singapore

10.3390/ph5040353