Businesses - Biosimilars - EtanerRel

EtanerRel (Etanercept) is a competitive inhibitor of TNF binding to its cell surface receptors, and thereby inhibits the biological activity of TNF. TNF and lymphotoxin are pro-inflammatory cytokines that bind to two distinct cell surface receptors: the 55- kilodalton (p55) and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs). The mechanism of action of EtanerRel is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive. EtanerRel may also modulate biologic responses controlled by additional downstream molecules (e.g., cytokines, adhesion molecules, or proteinases) that are induced or regulated by TNF.

EtanerRel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). EtanerRel can be initiated in combination with methotrexate (MTX) or used alone. EtanerRel is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients of two years and older. EtanerRel is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis and improving physical function in patients with psoriatic arthritis (PsA). EtanerRel can be used with or without methotrexate. EtanerRel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS). EtanerRel is indicated for the treatment of patients four years or older with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

EtanerRel is available as multi-dose vial of lyophilized etanercept containing 25 mg of Etanercept, to be reconstituted with 1ml of bacteriostatic water for injection (reconstituted etanercept concentrate contains approximately 25 mg/mL of etanercept). EtanerRel is administered by subcutaneous (SC) injection.