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

• Main Authors: Joseph E. McClellan (Author), Sesselja Ómarsdóttir (Author), Nivedita Roy (Author), Verena Berger (Author), Cecilia Michel (Author), Fausto Berti (Author)
• Format: Book
• Published: SAGE Publishing, 2024-01-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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 produ...