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SB8, an approved bevacizumab biosimilar based on totality of evidence: scientific justification of extrapolation.
Peeters, Marc; Lipp, Hans-Peter; Park, Minjeong; Yoon, Ye Chan; Arnold, Dirk.
Afiliação
  • Peeters M; Antwerp University Hospital, 2650, Edegem, Belgium.
  • Lipp HP; University Hospital Tübingen, 72076, Tübingen, Germany.
  • Park M; Samsung Bioepis Co., Ltd, Incheon, 21987, Republic of Korea.
  • Yoon YC; Samsung Bioepis Co., Ltd, Incheon, 21987, Republic of Korea.
  • Arnold D; Asklepios Tumorzentrum Hamburg, AK Klinik Altona, 22763, Hamburg, Germany.
Future Oncol ; 19(6): 427-450, 2023 Feb.
Article em En | MEDLINE | ID: mdl-36883661
SB8 is a biosimilar of bevacizumab based on its similarity demonstrated by physicochemical, functional, non-clinical and clinical studies. Supported by the concept of extrapolation, SB8 was authorized and is used in a similar manner across all types of tumors as reference bevacizumab. Furthermore, SB8 offers convenience with prolonged stability compared with reference bevacizumab in diluted form. Although a biosimilar must demonstrate biosimilarity to a reference product with the 'totality of evidence' in a stringent regulatory process for marketing authorization, some concerns remain among healthcare practitioners, particularly about extrapolation. This review summarizes the concepts of the totality of evidence and extrapolation in biosimilar development and the role of bevacizumab biosimilars in the management of metastatic colorectal cancer as an extrapolated indication.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias Retais / Neoplasias do Colo / Medicamentos Biossimilares Limite: Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias Retais / Neoplasias do Colo / Medicamentos Biossimilares Limite: Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article