Amgevita Description

AMGEVITA (adalimumab) is a biosimilar medicine to the reference product HUMIRA (Adalimumab). The comparability of AMGEVITA with HUMIRA has been demonstrated with regard to physicochemical characteristics and efficacy and safety outcomes (see Pharmacology: Clinical Trials under Actions and Adverse Reactions). The evidence for comparability supports the use of AMGEVITA for the listed indications.
AMGEVITA (adalimumab) is a recombinant human immunoglobulin (IgG1) monoclonal antibody containing only human peptide sequences. AMGEVITA was created using phage display technology resulting in fully human heavy and light chain variable regions, which confer specificity to human tumor necrosis factor (TNF), and human IgG1 heavy chain and kappa light chain sequences. AMGEVITA binds with high affinity and specificity to soluble tumor necrosis factor (TNF-alpha) but not lymphotoxin (TNF-beta). Adalimumab is produced by recombinant DNA technology in a mammalian cell expression system. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons.
AMGEVITA is supplied as a sterile, preservative-free solution of adalimumab for subcutaneous administration.
Excipients/Inactive Ingredients: Glacial acetic acid, Sucrose, Polysorbate 80, Sodium hydroxide (for pH adjustment), Water for injections.