Biosimilars in India; current status and future perspectives

Many key biologics are scheduled to lose their patent by the year 2020, which will provide the opportunity to other biopharmaceutical companies to develop the similar biologics. Biosimilar or similar biologic used has increased in the recent year following the approval of the first biosimilar in ear...

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Bibliographic Details
Published in:Journal of pharmacy & bioallied science 2019-01, Vol.11 (1), p.12-15
Main Authors: Meher, Bikash, Balan, Sakthi, Mohanty, Rashmi, Jena, Monalisa, Das, Smita
Format: Article
Language:English
Subjects:
Analysis
Biological products
Biopharmaceuticals
Biosimilar pharmaceuticals
Biosimilars
Cancer therapies
Deoxyribonucleic acid
DNA
Drugs
European Medicines Agency
FDA approval
Food and Drug Administration
Gene expression
Genetic engineering
Manufacturing
Marketing
Medical care, Cost of
Pharmaceutical industry
Regulatory agencies
Review
similar biologics
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Description
Summary:Many key biologics are scheduled to lose their patent by the year 2020, which will provide the opportunity to other biopharmaceutical companies to develop the similar biologics. Biosimilar or similar biologic used has increased in the recent year following the approval of the first biosimilar in early 2000. India is one of the leading manufacturers of similar biologics. India has developed a new guideline in 2012 for the pre- and post-marketing approval of similar biologics.
ISSN:0975-7406
0976-4879
0975-7406
DOI:10.4103/jpbs.JPBS_167_18