Health Canada Approves Merck’s Etanercept Biosimilar for New Indications

On September 15, 2020, Merck Canada Inc., an affiliate of Merck & Co., Inc., announced that Health Canada approved BRENZYS® (etanercept) for the following additional indications:

  • Adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy;
  • Pediatric patients ages 4 to 17 years with chronic severe PsO who are candidates for systemic therapy or phototherapy;
  • Reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis and improving physical function in adult patients with psoriatic arthritis (PsA); and
  • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 to 17 years who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).

BRENZYS® is a biosimilar to Amgen’s ENBREL®, a tumour necrosis factor (TNF) inhibitor.  According to the press release, BRENZYS® was previously approved for moderate-to-severe rheumatoid arthritis (RA) in adults and ankylosing spondylitis. Comparability between BRENZYS® and ENBREL® had been demonstrated by clinical efficacy and safety studies in patients with rheumatoid arthritis, although randomized clinical trials have not been conducted to compare BRENZYS® to ENBREL® in patients with psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, juvenile idiopathic arthritis and pediatric psoriasis.