title: Biosimilars: current scientific and regulatory considerations.
abstract: 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.
authors: Preeta Kaur
authors: PK
authors: Chugh
authors: Department of Pharmacology, Vardhman Mahavir Medical College and Associated Safdarjung Hospital, House No. 73, G.F., Hemkunt Colony, Greater Kailash Part I, New Delhi 110048, India. docpreeta@yahoo.com.
authors: Vandana
authors: V
authors: Roy
mesh_terms: D000818:Animals; D001688:Biological Products / Q000008:administration & dosage* / Q000191:economics / Q000592:standards; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage* / Q000191:economics / Q000592:standards; D017046:Cost Savings; D016527:Drug Costs; D004335:Drug and Narcotic Control; D006801:Humans; D010330:Patents as Topic
chemical_list: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals