The totality of evidence approach in the development of AVT02 (adalimumab), a biosimilar to Humira.

ABSTRACT: The development of a biosimilar is based on comparative structural, physicochemical, functional and clinical assessments. The sum of these analyses encompasses the 'totality of evidence', which demonstrates no clinically meaningful differences between the biosimilar and the reference product (RP). Once biosimilarity has been established, provided there is suitable scientific justification, clinical data may be extrapolated to other indications of the RP. AVT02 has been developed as a biosimilar to high-concentration, low-volume Humira (adalimumab), an anti-tumour necrosis factor-alpha monoclonal antibody approved for various chronic inflammatory indications. The totality of evidence for AVT02 is described, supporting its approval as an adalimumab biosimilar for all approved indications glo

SUBMITTER: McClellan JE 

PROVIDER: S-EPMC10799607 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature