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On the Manufacturers of Biosimilars in Asia.
- Source :
- Clinical Pharmacology & Therapeutics; Jan2023, Vol. 113 Issue 1, p23-26, 4p
- Publication Year :
- 2023
-
Abstract
- Over the past 2 decades, biosimilars have created an opportunity for access to affordable medicines globally. The development process includes robust analytical and functional comparability, equivalent pharmacokinetic profile, and demonstration of lack of any meaningful clinical differences. In this brief opinion article, we offer an overview of the major aspects that are involved in biosimilar development and regulatory requirements in Asia in order to facilitate a standardized process that can enable cost‐effective development of biosimilars. [ABSTRACT FROM AUTHOR]
- Subjects :
- BIOSIMILARS
MANUFACTURING industries
PHARMACOKINETICS
DRUGS
Subjects
Details
- Language :
- English
- ISSN :
- 00099236
- Volume :
- 113
- Issue :
- 1
- Database :
- Complementary Index
- Journal :
- Clinical Pharmacology & Therapeutics
- Publication Type :
- Academic Journal
- Accession number :
- 160934597
- Full Text :
- https://doi.org/10.1002/cpt.2750