CHRS

Humira® (adalimumab) Biosimilar - CHS-1420

Anti-TNF (tumor necrosis factor)

Phase 3 (BLA Filing)

Exp Date

H2 2020

Amp Volatility Score

Catalyst Info & Data Links

TITLE: Humira® (adalimumab) Biosimilar - CHS-1420 for Anti-TNF - BLA Filing


WHAT IS THE CATALYST EVENT?

  • BLA Filing


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?

  • H2 2020


PRIOR DATA/EVENTS

PRESS RELEASE

POSTERS


PRESENTATIONS


PUBLICATIONS

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).



Updated by HC

#CHRS, #Humira®, #adalimumab, #Biosimilar, #CHS-1420, #Anti-TNF, #tumor_necrosis_factor

Prior Data (click to view full image)

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