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. 2012 Jan;44(1):12-4.
doi: 10.4103/0253-7613.91859.

Biosimilars: current perspectives and future implications

Monika Misra  1
Affiliations

Biosimilars: current perspectives and future implications

Monika Misra. Indian J Pharmacol. 2012 Jan.

Abstract

Biosimilars are biological products that are the replicas of their innovator biopharmaceuticals. These are developed after patent expiration of innovator biopharmaceuticals and are submitted for separate marketing approval. In view of the structural and manufacturing complexities of biopharmaceuticals, biosimilars should not be considered as "biological generics". These are rather unique molecules with limited data at time of approval, so there are concerns about the safety and efficacy of biosimilars. This article will address the differences between biosimilars and chemical generics, issues of concern with the use of biosimilars and need of appropriate regulations for their approval.

Keywords: Biopharmaceuticals; biosimilars; generic drugs.

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Conflict of interest statement

Conflict of Interest: None declared.

Figures

Figure 1
Figure 1
Manufacture of biopharmaceuticals and sources of variation between manufacture of innovator biopharmaceutical and biosimilar
See this image and copyright information in PMC

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