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Update on Drugs and Drug News: November-December 2016


Name/Company Approval Dates and Comments

Brodalumab for SC injection
Lumicef®
Kyowa Hakko Kirin

The Ministry of Health, Labour and Welfare (MHLW) in Japan approved this fully human anti-interleukin (IL)-17 receptor A antibody in July 2016 as a second-line treatment for psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, and psoriatic erythroderma. Brodalumab binds with high affinity to IL-17 receptor A, thereby inhibiting several pro-inflammatory cytokines from the IL-17 family, which are thought to contribute to the pathophysiology associated with psoriasis.

Etanercept-szzs for SC injection
Erelzi™
Sandoz Inc., a Novartis division

In August 2016, the US FDA approved Erelzi™ (etanercept-szzs), a tumor necrosis factor (TNF) blocker biosimilar to Enbrel® (etanercept, Amgen Inc.) for all indications included in the reference product label, including moderate to severe rheumatoid arthritis, moderate to severe polyarticular juvenile idiopathic arthritis, active psoriatic arthritis, active ankylosing spondylitis, and chronic moderate to severe plaque psoriasis.

Biosimilar of etanercept for SC injection
Brenzys™
Samsung Bioepis Merck Canada

Health Canada approved Brenzys™ (also known as SB4), a biosimilar referencing Enbrel® (etanercept, Amgen Inc.) in August 2016. This is the first anti-TNF biosimilar available in Canada. Although the originator biological Enbrel® is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis, Brenzys™ has only been approved for the treatment of adult patients with moderate to severe rheumatoid arthritis and ankylosing spondylitis. Prior to receiving approval in Canada, the SB4 etanercept biosimilar received regulatory approvals from Korea's Ministry of Food and Drug Safety (MFDS) as Brenzys™ in September 2015, the European Commission (EC) as Benepali® in January 2016, and Australia's Therapeutic Goods Administration (TGA) as Brenzys™ in July 2016.

Adalimumab-atto for SC injection
Amjevita™
Amgen Inc.

In September 2016 the FDA approved the first adalimumab biosimilar Amjevita™, an anti-TNFa monoclonal antibody biosimilar to Humira® (AbbVie Inc.). Amjevita™ is indicated to treat seven inflammatory diseases, including psoriatic arthritis, moderate to severe chronic plaque psoriasis, moderate to severe rheumatoid arthritis, moderate to severe polyarticular juvenile idiopathic arthritis, adult moderate to severe Crohn's disease, ankylosing spondylitis, and moderate to severe ulcerative colitis. Treatment is delivered in prefilled syringe and autoinjector doses.

Propranolol hydrochloride oral solution 3.75 mg/ml
Hemangiol®
Pierre Fabre Dermo-Cosmétique

Health Canada approved the beta-adrenergic blocker propranolol hydrochloride in September 2016 for the treatment of proliferating infantile hemangioma requiring systemic therapy: life- or functionthreatening hemangioma, ulcerated hemangioma with pain and/or lack of response to simple wound care measures, and hemangioma with a risk of permanent scarring or disfigurement. Treatment should be initiated in infants aged 5 weeks to 5 months.

Calcipotriol 50 mcg/g + betamethasone dipropionate 0.5 mg/g foam
Enstilar®
Leo Pharma

In September 2016, Health Canada approved this fixed combination containing a vitamin D3 derivative, calcipotriol, and corticosteroid, betamethasone dipropionate, for the topical treatment of psoriasis vulgaris in patients ≥18 years of age. Both in vitro and clinical studies support this novel delivery system as having enhanced penetration of calcipotriol and betamethasone dipropionate over Dovobet® ointment, demonstrating a slight but significant increase in potency.


In this issue:

  1. A Review of Ixekizumab, an Anti-Interleukin-17A Monoclonal Antibody, for Moderate-to-Severe Plaque Psoriasis
  2. Update on Efinaconazole 10% Topical Solution for the Treatment of Onychomycosis
  3. Update on Drugs and Drug News - November-December 2016