Περίληψη:
Biologics have been used increasingly in the treatment and supportive care of cancer; however, their high cost places a significant burden on healthcare systems. The expiration of patents for biologics has led to the development of biosimilars, with the aim of reducing cost and increasing accessibility to novel treatments, which are affordable for a greater number of patients. Biosimilars are highly similar but not identical to the reference products; therefore, strict regulatory requirements have been formed for their approval. This ensures that there are no clinically meaningful differences compared with respective biologics, with regard to purity, safety and efficacy. In 2003, a regulatory framework for the approval of biosimilars was established in Europe, whereas the USA did not implement a framework until 2009, when the Biologics Price Competition and Innovation Act was formed. A number of biosimilars have currently been approved in oncology and the number is expected to rise in the near future. More than 10 years of evidence has revealed that biosimilars are safe and effective; however healthcare professionals need to be further educated to eliminate potential misconceptions and integrate biosimilars into routine clinical practice. The present review aims to provide an overview of the biosimilars used in Europe and the USA, present their main benefits and challenges, and discuss their current and future roles in medical oncology. © 2020 Spandidos Publications. All rights reserved.
Συγγραφείς:
Konstantinidou, S.
Papaspiliou, A.
Kokkotou, E.
Λέξεις-κλειδιά:
bevacizumab; biosimilar agent; epidermal growth factor receptor 2; filgrastim; human growth hormone; pegfilgrastim; pelmeg n; recombinant alpha2a interferon; rituximab; trastuzumab; vasculotropin, amino acid sequence; antibody dependent cellular cytotoxicity; Article; cancer chemotherapy; cancer hormone therapy; chemical structure; chronic lymphatic leukemia; clinical practice; cost effectiveness analysis; drug cost; drug efficacy; drug purity; drug safety; glioblastoma; health care cost; health care personnel; health care system; human; human epidermal growth factor receptor 2 positive breast cancer; immunogenicity; in vitro study; in vivo study; kidney metastasis; medication error; nonhodgkin lymphoma; oncology; oncology ward; pharmacovigilance; preclinical study; randomized controlled trial (topic); stomach cancer; tumor growth; uterine cervix carcinoma; uterine tube carcinoma
