Biosimilars in India; Current Status and Future Perspectives

被引：24

作者：

Meher, Bikash R. ^{[1
]}

Balan, Sakthi ^{[2
]}

Mohanty, Rashmi R. ^{[3
]}

Jena, Monalisa ^{[1
]}

Das, Smita ^{[4
,5
]}

机构：

[1] All India Inst Med Sci, Dept Pharmacol, Bhubaneswar, Odisha, India

[2] Srivenkateshwaraa Med Coll Hosp & Res Ctr, Dept Pharmacol, Pondicherry, India

[3] All India Inst Med Sci, Dept Gen Med, Bhubaneswar, Odisha, India

[4] Inst Med Sci, Dept Pharmacol, Bhubaneswar, Odisha, India

[5] Sum Hosp, Bhubaneswar, Odisha, India

来源：

JOURNAL OF PHARMACY AND BIOALLIED SCIENCES | 2019年 / 11卷 / 01期

关键词：

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

D O I：

10.4103/jpbs.JPBS_167_18

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

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.

引用

页码：12 / 15

页数：4

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