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.
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