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J Pharm Bioallied Sci. 2019 Jan-Mar;11(1):12-15. doi: 10.4103/jpbs.JPBS_167_18.

Biosimilars in India; Current Status and Future Perspectives.

Author information

1
Department of Pharmacology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.
2
Department of Pharmacology, Srivenkateshwaraa Medical College Hospital and Research Centre, Puducherry, India.
3
Department of General Medicine, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.
4
Department of Pharmacology, Institute of Medical Sciences and Sum Hospital, Bhubaneswar, Odisha, India.

Abstract

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.

KEYWORDS:

Biosimilars; European Medicines Agency; Food and Drug Administration; similar biologics

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