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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