The article provides an overview of biosimilars, focusing on their development, quality, regulatory issues, and management in healthcare. Biosimilars are biological medicines that are developed to be similar to reference products (RPs) in terms of safety, quality, and effectiveness. They are not generic substitutes but are created through a rigorous step-by-step process that includes analytical, functional, and nonclinical evaluations, as well as clinical trials. The development of biosimilars aims to establish similar efficacy, safety, and immunogenicity, rather than demonstrating clinical benefit as with RPs. Despite advancements, controversies and misconceptions remain regarding immunogenicity, extrapolation, interchangeability, substitution, and nomenclature. The article highlights the importance of cooperation between regulators and developers to ensure patient access to these therapies while maintaining high standards of quality, safety, and efficacy. It also addresses regulatory and manufacturing requirements, post-marketing safety monitoring, and clinical decision-making for the use of biosimilars. Key points include the role of biosimilars in increasing patient access, the need for understanding biosimilarity, and the challenges in manufacturing and characterizing biosimilars. The article concludes by emphasizing the importance of realistic approaches, such as open communication and informed decision-making, to maximize the benefits of biosimilars.The article provides an overview of biosimilars, focusing on their development, quality, regulatory issues, and management in healthcare. Biosimilars are biological medicines that are developed to be similar to reference products (RPs) in terms of safety, quality, and effectiveness. They are not generic substitutes but are created through a rigorous step-by-step process that includes analytical, functional, and nonclinical evaluations, as well as clinical trials. The development of biosimilars aims to establish similar efficacy, safety, and immunogenicity, rather than demonstrating clinical benefit as with RPs. Despite advancements, controversies and misconceptions remain regarding immunogenicity, extrapolation, interchangeability, substitution, and nomenclature. The article highlights the importance of cooperation between regulators and developers to ensure patient access to these therapies while maintaining high standards of quality, safety, and efficacy. It also addresses regulatory and manufacturing requirements, post-marketing safety monitoring, and clinical decision-making for the use of biosimilars. Key points include the role of biosimilars in increasing patient access, the need for understanding biosimilarity, and the challenges in manufacturing and characterizing biosimilars. The article concludes by emphasizing the importance of realistic approaches, such as open communication and informed decision-making, to maximize the benefits of biosimilars.