Enbrel® (etanercept) Biosimilar
ANTI-TNF (tumor necrosis factor)
Phase 2 (BLA Filing)
Amp Volatility Score
Catalyst Info & Data Links
TITLE: Enbrel® (etanercept) Biosimilar in Anti-TNF - BLA Filing
WHAT IS THE CATALYST EVENT?
WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?
MECHANISM OF ACTION / RATIONALE
TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. It plays an important role in the inflammatory processes of RA, polyarticular JIA, PsA, and AS and the resulting joint pathology. In addition, TNF plays a role in the inflammatory process of PsO. Elevated levels of TNF are found in involved tissues and fluids of patients with RA, JIA, PsA, AS, and PsO.
Two distinct receptors for TNF (TNFRs), a 55 kilodalton protein (p55) and a 75 kilodalton protein (p75), exist naturally as monomeric molecules on cell surfaces and in soluble forms. Biological activity of TNF is dependent upon binding to either cell surface TNFR.
Etanercept is a dimeric soluble form of the p75 TNF receptor that can bind TNF molecules. Etanercept inhibits binding of TNF- and TNF- (lymphotoxin alpha [LT-]) to cell surface TNFRs, rendering TNF biologically inactive. In in vitro studies, large complexes of etanercept with TNF- were not detected and cells expressing transmembrane TNF (that binds Enbrel) are not lysed in the presence or absence of complement.
source - FDA Label (section 12.1)
Updated by HC
#CHRS, #Enbrel®, #etanercept, #Biosimilar, #Anti-TNF, #BLA
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