Phase 3 (BLA Filing)
Amp Volatility Score
Catalyst Info & Data Links
TITLE: Humira® (adalimumab) Biosimilar - CHS-1420 for Anti-TNF - BLA Filing
WHAT IS THE CATALYST EVENT?
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
01-2020: 38th Annual J.P. Morgan Global Healthcare Conference (slide 12, 26, 28-29)
MECHANISM OF ACTION / RATIONALE
Adalimumab binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also lyses surface TNF expressing cells in vitro in the presence of complement. Adalimumab does not bind or inactivate lymphotoxin (TNF-beta). TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Elevated levels of TNF are found in the synovial fluid of patients with RA, JIA, PsA, and AS and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases. Increased levels of TNF are also found in psoriasis plaques. In Ps, treatment with HUMIRA may reduce the epidermal thickness and infiltration of inflammatory
The relationship between these pharmacodynamic activities and the mechanism(s) by which HUMIRA exerts its clinical effects is unknown.
Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 1-2 X 10-10M).
source - FDA Label (section 12.1)
Updated by HC
#CHRS, #Humira®, #adalimumab, #Biosimilar, #CHS-1420, #Anti-TNF, #tumor_necrosis_factor
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