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Fubelv (etanercept)

Region

🇪🇺 EU

Active substance

etanercept

Company

Biosimilar Collaborations Ireland Limited

Status

Authorised

Therapeutic area

Arthritis, Rheumatoid; Arthritis, Juvenile; Arthritis, Psoriatic; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis; Spondylitis, Ankylosing; Psoriasis

CHMP opinion

Thu 26 Feb 2026

EU approval

Thu 23 Apr 2026

Designations

Biosimilar, Additional monitoring

Application

EMEA/H/C/006738

ATC

L04AB01

Official record

www.ema.europa.eu

Indication

Rheumatoid arthritisFubelv in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.Fubelv can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.Fubelv is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.Fubelv, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.Juvenile idiopathic arthritisTreatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Psoriatic arthritisTreatment of active and progressive psoriatic arthritis in adults when the response to previous disease- modifying antirheumatic drug therapy has been inadequate. Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease. Axial spondyloarthritisAnkylosing spondylitisTreatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.Non-radiographic axial spondyloarthritisTreatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).Plaque psoriasisTreatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA).Paediatric plaque psoriasisTreatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Regulatory milestones

Same substance in other markets

• 🇪🇺 Erelzi Authorised · Sandoz GmbH
• 🇪🇺 Benepali Authorised · Samsung Bioepis NL B.V.
• 🇪🇺 Enbrel Authorised · Pfizer Europe MA EEIG
• 🇪🇺 Nepexto Authorised · Biosimilar Collaborations Ireland Limited
• 🇪🇺 Lifmior Lapsed · Pfizer Europe MA EEIG

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.