Biosimilars: Current Scientific and Regulatory Considerations

Author(s): Preeta Kaur Chugh, Vandana Roy

Journal Name: Current Clinical Pharmacology
Continued as Current Reviews in Clinical and Experimental Pharmacology

Volume 9 , Issue 1 , 2014


The widespread use of biologics has paved way for newer options in therapeutics for once incurable illnesses. Their large and complex protein structure, post-translational modifications, elaborate manufacturing/production process and risk for immunogenicity adds to the uniqueness of a biologic product. Patent expiration of innovator biologics has led to the development of biosimilars; biologics similar/comparable to the reference product in terms of quality, safety and efficacy. We discuss the clinical safety and regulatory requirements for biosimilars in various countries across the world. Future holds promise for biosimilars to provide affordable, efficacious and safe treatment to a vast majority of patients with significant cost savings to the nation.

Keywords: Biologic, biosimilar, immunogenicity, patent, regulation, safety.

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Article Details

Year: 2014
Page: [53 - 63]
Pages: 11
DOI: 10.2174/15748847113089990066

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