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Date: 2017-02-13

Type of information: Positive opinion for the 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: * On December 15, 2016,  the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted  a positive recommendation recommending the approval of Lifmior® (etanercept) received for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis.

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:

Is general: Yes