BIOSIMILAR CURRENT STATUS IN INDIA
DOI:
https://doi.org/10.22159/ajpcr.2017.v10i1.14814Abstract
Biosimilars are biological products that are the replica 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.†The objective of the article will address the current Indian scenario conducting the clinical trial biological and biosimilar product regulatory requirements for approval of biological and biosimilar product. The New India Guidelines Draft Guidelines on Similar Biologics were announced in June 2012, by the department of biotechnology at Boston bio and available in India.
Keywords: Biosimilars, Biopharmaceutical, Innovator biopharmaceuticals.
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