Skin treatments introduced in 2020, categorized by type/class of therapy below:

Actinic Keratosis


Tirbanibulin ointment 1%



Trade Name: Klisyri®

Company: Almirall/Athenex


Indication/Description: This novel, first-in-class microtubule inhibitor was approved for the topical treatment of actinic keratosis of the face or scalp.


Approving Regulatory Agency: US FDA



Anti-Acne Agents


Clascoterone 1% cream



Trade Name: Winlevi®

Company: Cassiopea SpA


Indication/Description: Approval was granted to clascoterone (cortexolone 17α-propionate) 1% cream for treating acne vulgaris in patients aged ≥12 years. This is the first acne drug with a new mechanism of action to gain regulatory approval in the US in the last 40 years.


Approving Regulatory Agency: US FDA



Anti-Cancer Agents


Pembrolizumab for IV use



Trade Name: Keytruda®

Company: Merck & Co.


Indication/Description: An additional indication was granted for this programmed death receptor-1 (PD-1)-blocking antibody as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation.


Approving Regulatory Agency: US FDA





Pomalidomide capsules



Trade Name: Pomalyst®

Company: Bristol Myers Squibb


Indication/Description: An expanded indication for pomalidomide was granted to treat patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy, or in patients with Kaposi sarcoma who are HIV-negative. This is the only oral and first new therapeutic option for Kaposi sarcoma in more than 20 years.


Approving Regulatory Agency: US FDA





Sonidegib capsules



Trade Name: Odomzo®

Company: Sun Pharma


Indication/Description: Approval was granted to this oral antineoplastic agent (a hedgehog pathway inhibitor) for treating adult patients with histologically confirmed locally advanced basal cell carcinoma that is not amenable to radiation therapy or curative surgery.


Approving Regulatory Agency: Health Canada





Tazemetostat tablets



Trade Name: Tazverik™

Company: Epizyme, Inc.


Indication/Description: Accelerated approval of tazemetostat was granted for the treatment of patients aged ≥16 years with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.


Approving Regulatory Agency: US FDA





Triplet melanoma therapy



Trade Name: Tecentriq® + Cotellic® and Zelboraf®

Company: Genentech


Indication/Description: This triplet regimen of atezolizumab (Tecentriq®, anti-PD-L1 antibody) + cobimetinib (Cotellic®, MEK inhibitor) and vemurafenib (Zelboraf®, BRAF kinase inhibitor) was approved for treating BRAF V600 mutation-positive advanced melanoma patients. This is the first FDA-approved combination for treating metastatic melanoma that brings together immunotherapy with targeted therapies.


Approving Regulatory Agency: US FDA



Atopic Dermatitis


Crisaborole ointment 2%



Trade Name: Eucrisa®

Company: Pfizer


Indication/Description: A supplemental new drug application was approved, expanding the indication of crisaborole to include treatment of mild-to-moderate atopic dermatitis in children ages 3 months to 24 months.


Approving Regulatory Agency: US FDA





Dupilumab SC use



Trade Name: Dupixent®

Company: Regeneron/Sanofi


Indication/Description: Dupilumab was approved for treating children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. It is the only biologic approved for this population.


Approving Regulatory Agency: US FDA



Autoinflammatory Disease


Anakinra SC use



Trade Name: Kineret®

Company: Swedish Orphan Biovitrum (Sobi™)


Indication/Description: The supplemental Biologics License Application for anakinra was approved for treating deficiency of IL-1 receptor antagonist (DIRA), an ultra-rare, autoinflammatory disease caused by a genetic mutation in the IL1RN gene, resulting in life-threatening systemic inflammation with skin and bone involvement.


Approving Regulatory Agency: US FDA



Cellulite


Collagenase clostridium histolyticum-aaes SC use



Trade Name: Qwo™

Company: Endo International


Indication/Description: Injectable collagenase clostridium histolyticum-aaes was approved for the treatment of moderate to severe cellulite in the buttocks of adult women.


Approving Regulatory Agency: US FDA



Dermal Fillers


HA injectable filler



Trade Name: Juvéderm® Voluma™ XC

Company: Allergan Aesthetics


Indication/Description: This hyaluronic acid (HA)-based dermal filler was approved for augmentation of the chin region to improve the chin profile in patients aged >21 years.


Approving Regulatory Agency: US FDA





HA injectable filler



Trade Name: Restylane® Kysse™

Company: Galderma


Indication/Description: Approval was granted to this preparation of HA-based dermal filler for lip augmentation and the correction of upper perioral rhytids in adults aged >21 years.


Approving Regulatory Agency: US FDA



Head Lice


Abametapir 0.74% lotion



Trade Name: Xeglyze™

Company: Dr. Reddy’s Laboratories


Indication/Description: Approval was granted to abametapir lotion for the topical treatment of head lice infestation in patients ≥6 months of age.


Approving Regulatory Agency: US FDA



Hereditary Angioedema


Berotralstat capsules



Trade Name: Orladeyo™

Company: BioCryst Pharmaceuticals


Indication/Description: Oral, once-daily berotralstat, a plasma kallikrein inhibitor, was approved for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients aged ≥12 years.


Approving Regulatory Agency: US FDA





C1 esterase inhibitor (human) SC use



Trade Name: Haegarda®

Company: CSL Behring


Indication/Description: An expanded pediatric indication was approved for Haegarda® for routine prophylaxis to prevent HAE attacks in patients aged ≥6 years.


Approving Regulatory Agency: US FDA



Hidradenitis Suppurativa


Adalimumab biosimilar SC use



Trade Name: Amgevita®

Company: Amgen Canada


Indication/Description: This biosimilar to adalimumab (Humira®) was approved for treating nine chronic inflammatory diseases, including psoriatic arthritis, plaque psoriasis and hidradenitis suppurativa.


Approving Regulatory Agency: Health Canada





Adalimumab-fkjp SC use



Trade Name: Hulio®

Company: Viatris (Canada)/Mylan (US) Fujifilm Kyowa Kirin


Indication/Description: This biosimilar to adalimumab (Humira®) was approved for the treatment of multiple chronic diseases, including plaque psoriasis, psoriatic arthritis and hidradenitis suppurativa.


Approving Regulatory Agency: Health Canada, US FDA





Adalimumab biosimilar SC use



Trade Name: Hyrimoz®

Company: Sandoz Canada


Indication/Description: Marketing authorization was granted to this tumor necrosis factor (TNF)-alpha blocker referencing adalimumab (Humira®) for treating the same nine indications, including psoriasis, psoriatic arthritis and hidradenitis suppurativa.


Approving Regulatory Agency: Health Canada, US FDA





Adalimumab biosimilar SC use



Trade Name: Idacio®

Company: Fresenius Kabi


Indication/Description: This biosimilar referencing adalimumab (Humira®) was approved across all eligible indications, including plaque psoriasis, psoriatic arthritis and hidradenitis suppurativa.


Approving Regulatory Agency: Health Canada





Golimumab IV use



Trade Name: Simponi® Aria™

Company: Janssen Pharmaceutical


Indication/Description: Golimumab was approved for treating patients ≥2 years of age with active polyarticular juvenile idiopathic arthritis; this expanded indication also includes active psoriatic arthritis for this patient population.

Approving Regulatory Agency: US FDA





Guselkumab SC use



Trade Name: Tremfya®

Company: Janssen Pharmaceuticals


Indication/Description: An additional indication was approved for this IL-23 receptor inhibitor to treat adult patients with active psoriatic arthritis.

Approving Regulatory Agency: US FDA





Infliximab biosimilar IV use



Trade Name: Avsola™

Company: Amgen Canada


Indication/Description: This anti-TNF-alpha monoclonal antibody was authorized for all approved indications of the reference product, infliximab (Remicade®), including chronic severe plaque psoriasis and psoriatic arthritis.

Approving Regulatory Agency: Health Canada



Neurofibromatosis


Selumetinib capsules



Trade Name: Koselugo®

Company: AstraZeneca, Merck


Indication/Description: This inhibitor of mitogen-activated protein kinase kinases 1 and 2 (MEK1/2) was approved for the treatment of pediatric patients aged

≥2 years with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). This is the first regulatory approval of a therapeutic agent to treat NF1 PN.


Approving Regulatory Agency: US FDA



Psoriasis


Adalimumab biosimilar SC use



Trade Name: Amgevita®

Company: Amgen Canada


Indication/Description: This biosimilar to adalimumab (Humira®) was approved for treating nine chronic inflammatory diseases, including psoriatic arthritis, plaque psoriasis and hidradenitis suppurativa.


Approving Regulatory Agency: Health Canada





Adalimumab-fkjp SC use



Trade Name: Hulio®

Company: Viatris (Canada)/Mylan (US) Fujifilm Kyowa Kirin


Indication/Description: This biosimilar to adalimumab (Humira®) was approved for the treatment of multiple chronic diseases, including plaque psoriasis, psoriatic arthritis and hidradenitis suppurativa.


Approving Regulatory Agency: Health Canada, US FDA





Adalimumab biosimilar SC use



Trade Name: Hyrimoz®

Company: Sandoz Canada


Indication/Description: Marketing authorization was granted to this TNF blocker referencing adalimumab (Humira®) for treating the same nine indications, including psoriasis, psoriatic arthritis and hidradenitis suppurativa.


Approving Regulatory Agency: Health Canada





Adalimumab biosimilar SC use



Trade Name: Idacio®

Company: Fresenius Kabi


Indication/Description: This biosimilar referencing adalimumab (Humira®) was approved across all eligible indications including plaque psoriasis, psoriatic arthritis and hidradenitis suppurativa.


Approving Regulatory Agency: Health Canada





Infliximab biosimilar IV use



Trade Name: Avsola™

Company: Amgen Canada


Indication/Description: This anti-TNF-alpha monoclonal antibody was authorized for all approved indications of the reference product, infliximab (Remicade®), including chronic severe plaque psoriasis and psoriatic arthritis.

Approving Regulatory Agency: Health Canada





Ustekinumab SC use



Trade Name: Stelara®

Company: Janssen Pharmaceuticals


Indication/Description: An expanded indication was approved for ustekinumab, an interleukin (IL)-12 and IL-23 inhibitor, for the treatment of pediatric patients (6 to 11 years of age) with moderate to severe plaque psoriasis.

Approving Regulatory Agency: US FDA





Calcipotriene + betamethasone dipropionate cream



Trade Name: Wynzora®

Company: MC2 Therapeutics


Indication/Description: This first cream-based fixed dose combination of calcipotriene + betamethasone dipropionate, w/w 0.005%/0.064%, was approved for the once-daily topical treatment of plaque psoriasis in adults aged ≥18 years.

Approving Regulatory Agency: US FDA





Halobetasol propionate + tazarotene lotion



Trade Name: Duobrii™

Company: Bausch Health


Indication/Description: A new combination formulation corticosteroid/retinoid (0.01% w/w halobetasol propionate and 0.045% w/w tazarotene) lotion was approved for improving the signs and symptoms of plaque psoriasis.

Approving Regulatory Agency: Health Canada



Psoriatic Arthritis


Adalimumab biosimilar SC use



Trade Name: Amgevita®

Company: Amgen Canada


Indication/Description: This biosimilar to adalimumab (Humira®) was approved for treating nine chronic inflammatory diseases, including psoriatic arthritis, plaque psoriasis and hidradenitis suppurativa.


Approving Regulatory Agency: Health Canada





Adalimumab-fkjp SC use



Trade Name: Hulio®

Company: Viatris (Canada)/Mylan (US) Fujifilm Kyowa Kirin


Indication/Description: This biosimilar to adalimumab (Humira®) was approved for the treatment of multiple chronic diseases, including plaque psoriasis, psoriatic arthritis and hidradenitis suppurativa.


Approving Regulatory Agency: Health Canada, US FDA





Adalimumab biosimilar SC use



Trade Name: Hyrimoz®

Company: Sandoz Canada


Indication/Description: Marketing authorization was granted to this TNF blocker referencing adalimumab (Humira®) for treating the same nine indications, including psoriasis, psoriatic arthritis and hidradenitis suppurativa.


Approving Regulatory Agency: Health Canada





Adalimumab biosimilar SC use



Trade Name: Idacio®

Company: Fresenius Kabi


Indication/Description: This biosimilar referencing adalimumab (Humira®) was approved across all eligible indications including plaque psoriasis, psoriatic arthritis and hidradenitis suppurativa.


Approving Regulatory Agency: Health Canada





Golimumab IV use



Trade Name: Simponi® Aria™

Company: Janssen Pharmaceutical


Indication/Description: Golimumab was approved for treating patients ≥2 years of age with active polyarticular juvenile idiopathic arthritis; this expanded indication also includes active psoriatic arthritis for this patient population.

Approving Regulatory Agency: US FDA





Guselkumab SC use



Trade Name: Tremfya®

Company: Janssen Pharmaceuticals


Indication/Description: An additional indication was approved for this IL-23 receptor inhibitor to treat adult patients with active psoriatic arthritis.

Approving Regulatory Agency: US FDA





Infliximab biosimilar IV use



Trade Name: Avsola™

Company: Amgen Canada


Indication/Description: This anti-TNF-alpha monoclonal antibody was authorized for all approved indications of the reference product, infliximab (Remicade®), including chronic severe plaque psoriasis and psoriatic arthritis.

Approving Regulatory Agency: Health Canada



Rosacea


Minocycline foam 1.5%



Trade Name: Zilxi™

Company: Menlo Therapeutics


Indication/Description: Approval was granted to minocycline 1.5% topical foam for the treatment of inflammatory lesions of rosacea in adults. This approval marks the first minocycline product to be approved by the FDA for use in rosacea.


Approving Regulatory Agency: US FDA



Skin Therapy Letter uses reasonable efforts to include accurate and up-to-date information, we make no warranties or representations as to the accuracy, completeness, timeliness or reliability of the content and assume no liability or responsibility for any error or omission. The content primarily focuses on approvals issued by US and Canadian drug regulatory agencies, and is sourced from both regulatory and industry news releases.

Purchase PDF for $1.99