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- Title
Biosimilars in the Rest of the World: Developments in Lesser-Regulated Countries.
- Authors
RADER, RONALD A.
- Abstract
The article focuses on the development of biopharmaceutical products including biobetters and biogenerics in developing countries. Topics discussed include biogeneric approval based on clinical studies being implemented by Dr. Reddy's Laboratories Ltd. and Cipla Ltd., pharmaceutical companies in India and several companies in developing countries seeking development of good manufacturing practices (cGMP)-manufactured products. It also discusses the meaning of Reference Product.
- Subjects
BIOPHARMACEUTICS; DRUG factories; CURRENT good manufacturing practices; CIPLA Ltd.; DR. Reddy's Laboratories Ltd.; DEVELOPING countries
- Publication
BioProcessing Journal, 2013, Vol 12, Issue 4, p41
- ISSN
1538-8786
- Publication type
Article