Abstract

Biologics are highly sensitive large molecules with complex structure, difficult to characterize and reproduce, derived from living cells; used for treatment, diagnosis or prevention of disease. . Biosimilars are proteins that are similar to innovator biologics but not the same as they differ slightly in structure however with no clinically significant difference. Biologicals and Biosimilars are core part of modern medicines to manage and treat difficult and rare conditions. They have become an indispensible part of modern pharmacotherapy. The pharmaceutical and regulatory aspects of Biologicals and Biosimilars are reviewed in this article. Key words: Biologicals, Biosimilars, Regulatory Approval Process, Indian and WHO guidelines

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