TGA approves Brenzys (etanercept)

28 July 2016 - The TGA has approved a biosimilar to Pfizer's Enbrel.

The TGA approved Brenzys on 22 July 2016 for use in adults 18 years and older for the treatment of:

  • active, rheumatoid arthritis (RA) in patients who have had inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Brenzys can be used in combination with methotrexate.
  • severe, active rheumatoid arthritis to slow progression of disease-associated structural damage in patients at high risk of erosive disease.
  • the signs and symptoms of active and progressive psoriatic arthritis, when the response to previous disease-modifying antirheumatic therapy has been inadequate.
  • patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy.
    the signs and symptoms of active ankylosing spondylitis.
  • patients with active* non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or MRI change who have had an inadequate response to NSAIDs.

Read TGA approval of Brenzys

  

Michael Wonder

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Michael Wonder

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Outcome , Australia , Biosimilar