Date: 2017-02-13
Type of information: Granting of a Market Authorisation in the EU
Product name: Lifmior®
Compound: etanercept biosimilar
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Dermatological diseases - Rheumatic diseases
Action mechanism: TNF alpha inhibitor/fusion protein. Etanercept, is an anti-tumor necrosis factor (TNF) agent. By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases.
Company: Pfizer (USA - NY)
Disease: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis, paediatric plaque psoriasis
Latest news:
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2017-02-13
Favourable opinion UE: 2016-12-15
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news: