The totality of evidence approach in the development of AVT02 (adalimumab), a biosimilar to Humira
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). O...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2024-01-01
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| Series: | Therapeutic Advances in Chronic Disease |
| Online Access: | https://doi.org/10.1177/20406223231223286 |