Purpose: This article aims to analyse the key regulatory guidelines across the globe concerning biosimilars. Materials and methods: Review of the current literature. Results: Biosimilars are well regulated with the majority of regulators having enforced the guidelines for the development and approval, and new biosimilar drugs are appearing on the horizon to provide a therapeutic option to a wider population base because of its cost-effectiveness and proven safety. Due to their extensive analytical data, clinical data and pharmacovigilance studies, their development should not be considered similar to generic drugs. Conclusion: This review discusses the biosimilars, their regulation globally and their difference from generics from ophthalmic perspective.
Understanding biosimilars and its regulatory aspects across the globe: An ophthalmology perspective
Bandello F.;
2020-01-01
Abstract
Purpose: This article aims to analyse the key regulatory guidelines across the globe concerning biosimilars. Materials and methods: Review of the current literature. Results: Biosimilars are well regulated with the majority of regulators having enforced the guidelines for the development and approval, and new biosimilar drugs are appearing on the horizon to provide a therapeutic option to a wider population base because of its cost-effectiveness and proven safety. Due to their extensive analytical data, clinical data and pharmacovigilance studies, their development should not be considered similar to generic drugs. Conclusion: This review discusses the biosimilars, their regulation globally and their difference from generics from ophthalmic perspective.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
