Regulatory and clinical considerations for biosimilar oncology drugs

摘要: Summary Biological oncology products are integral to cancer treatment, but their high costs pose challenges patients, families, providers, and insurers. The introduction of biosimilar agents—molecules that similar in structure, function, activity, immunogenicity, safety the original biological drugs—provide opportunities both improve health-care access outcomes, reduce costs. Several international regulatory pathways have been developed expedite entry biosimilars into global marketplaces. first wave use was Europe India 2007. Oncology now widely marketed several countries Europe, Australia, Japan, China, Russia, India, South Korea. Their is emerging worldwide, with notable exception USA, where cost barriers approval exist. In this Review, we discuss summarise frameworks, clinical experiences, concerns.