CHRS

Enbrel® (etanercept) Biosimilar

ANTI-TNF (tumor necrosis factor)

Phase 2 (BLA Filing)

Exp Date

TBD

Amp Volatility Score

Catalyst Info & Data Links

TITLE: Enbrel® (etanercept) Biosimilar in Anti-TNF - BLA Filing


WHAT IS THE CATALYST EVENT?

  • TBD


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

  • TBD


PRIOR DATA/EVENTS

PRESS RELEASE

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.


Updated by HC

#CHRS, #Enbrel®, #etanercept, #Biosimilar, #Anti-TNF, #BLA

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