Health Canada approves Merck’s etanercept biosimilar for new indications

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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.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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