Open AccessBIOSIMILAR CURRENT STATUS IN INDIA
Author(s) -
Raju Kamaraj,
M Manju
Publication year - 2016
Publication title -
asian journal of pharmaceutical and clinical research
Language(s) - English
Resource type - Journals
eISSN - 2455-3891
pISSN - 0974-2441
DOI - 10.22159/ajpcr.2017.v10i1.14814
Subject(s) - biosimilar , innovator , biopharmaceutical , biological drugs , expiration date , product (mathematics) , medicine , microbiology and biotechnology , business , risk analysis (engineering) , biology , immunology , geometry , mathematics , finance , entrepreneurship , rheumatoid arthritis , food science
Biosimilars are biological products that are the replica of their innovator biopharmaceuticals. These are developed after patent expiration ofinnovator biopharmaceuticals and are submitted for separate marketing approval. In view of the structural and manufacturing complexities ofbiopharmaceuticals, biosimilars should not be considered as “biological generics.” The objective of the article will address the current Indian scenarioconducting the clinical trial biological and biosimilar product regulatory requirements for approval of biological and biosimilar product. The NewIndia Guidelines “Draft Guidelines on Similar Biologics were announced in June 2012, by the department of biotechnology at Boston bio and availablein India.Keywords: Biosimilars, Biopharmaceutical, Innovator biopharmaceuticals.