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.