Fubelv

Opinion

EMA has issued an opinion on this medicine

etanercept

Overview

On 26 February 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Fubelv, intended for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis, non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis. 

The applicant for this medicinal product is Biosimilar Collaborations Ireland Limited.

Fubelv will be available as 25 mg and 50 mg solutions for injection. The active substance of Fubelv is etanercept, an immunosuppressant (ATC code: L04AB01). Etanercept is a fusion protein, which preferentially binds to tumour necrosis factor alpha (TNF-α) and thereby inhibits its biological activity.

Fubelv is a biosimilar medicinal product. It is highly similar to the reference product Enbrel (etanercept), which was authorised in the EU on 3 February 2000. Data show that Fubelv has comparable quality, safety and efficacy to Enbrel.

The full indications are:

Rheumatoid arthritis

Fubelv 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 arthritis

Treatment 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 arthritis

Treatment 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 spondyloarthritis

Ankylosing spondylitis

Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Non-radiographic axial spondyloarthritis

Treatment 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 psoriasis

Treatment 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) (see section 5.1).

Paediatric plaque psoriasis

Treatment 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.

It is proposed that treatment with Fubelv should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis. Patients treated with Fubelv should be given the patient alert card.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Fubelv

Adopted Reference Number: EMADOC-1829012207-42793

Product details

• Name of medicine:
  Fubelv
• Active substance:
  etanercept
• International non-proprietary name (INN) or common name:
  etanercept
• Therapeutic area (MeSH):
  • Arthritis, Rheumatoid
  • Arthritis, Juvenile
  • Arthritis, Psoriatic
  • Axial Spondyloarthritis
  • Non-Radiographic Axial Spondyloarthritis
  • Spondylitis, Ankylosing
  • Psoriasis
• Anatomical therapeutic chemical (ATC) code:
  L04AB01
• EMA product number:
  EMEA/H/C/006738
• Biosimilar:

  This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

• Marketing authorisation applicant:
  Biosimilar Collaborations Ireland Limited
• Opinion adopted:
  26/02/2026
• Opinion status:
  Positive