Type/Class of TherapyGeneric/Trade/Company NamesIndication/DescriptionApproving Regulatory Agency
Antibiotic AgentsDelafloxacin for oral or IV infusion
Baxdela™
Ligand/Melinta
Delafloxacin was approved for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. Delafloxacin is a fluoroquinolone that exhibits activity against both gram-positive and gram-negative pathogens, including methicillin resistant Staphylococcus aureus (MRSA).US FDA
Ozenoxacin cream, 1%
Health Canada: Ozanex™, Cipher/Ferrer
US FDA: Xepi™, Medimetriks
This novel topical antibiotic was approved for the treatment of impetigo in patients aged ≥2 months. It is the first bacteriocidal topical antibiotic that has been shown to be effective against resistant bacteria such as MRSA. Ozenoxacin offers a short 5-day twice-daily dosing regimen and has shown bacteriological eradication as early as day 3 of treatment.Health Canada

US FDA

Secnidazole oral granules
Solosec™
Symbiomix Therapeutics
Secnidazole was approved for treating bacterial vaginosis (BV) in adult women. Secnidazole is a next-generation, 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties that enable delivery in a single dose, and is the first and only single-dose oral therapy for BV.US FDA
Anti-cancer AgentsAvelumab for IV injection
Bavencio®
EMD Serono/Merck KGaA
Avelumab, a human anti-programmed cell death-ligand PD-1/PD-L1 antibody, was approved for the treatment of adults and pediatric patients ≥12 years of age with metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy.Health Canada

US FDA

Brentuximab vedotin for IV infusion
Adcetris®
Seattle Genetics
Approval was granted to brentuximab vedotin for the treatment of adults with primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides who have received prior systemic therapy.US FDA
Atopic DermatitisDupilumab for SC injection
Dupixent®
Sanofi/Regeneron
Approval was granted to dupilumab, the first biologic for treating adults with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Dupilumab is a human monoclonal antibody that specifically inhibits overactive signaling of two key cytokines, interlukin (IL)-4 and IL-13.Health Canada

US FDA

European
Commission

Dermal FillersHyaluronic acid-based injectable dermal filler
Juvéderm® Vollure™ XC
Allergan plc
This hyaluronic acid (HA) dermal filler was approved for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults >21 years of age. It is formulated with the proprietary Vycross® technology, which blends different molecular weights of HA to provide a longer duration of effect. The product is known as Juvéderm® Volift™™ in Canada and Europe.US FDA
HA injectable filler
Revanesse® Ultra
Prollenium
Marketing clearance was granted to this non-animal cross-linked HA dermal filler. The product is indicated for injection into the mid to deep dermis, for correction of moderate to severe facial wrinkles and folds in adults ≥22 years of age.US FDA
HA injectable filler
RHA®2, RHA®3 & RHA®4
Teoxane Laboratories
These three HA dermal fillers received marketing clearance and are indicated for the correction of moderate to severe dynamic facial wrinkles and folds in adults aged ≥22 years.US FDA
Fabry DiseaseOral migalastat
Galafold™
Amicus Therapeutics
Approval was granted to migalastat, a first-in-class oral, small molecule, precision therapy for the long-term treatment of adults with a confirmed diagnosis of Fabry disease [deficiency of alphagalactosidase (alpha-Gal A)] and who have an alpha-Gal A mutation determined to be amenable by an in vitro assay.Health Canada
Hereditary AngioedemaPlasma-derived concentrate of C1 esterase inhibitor SC (human)
Haegarda®
CSL Behring
Approval was granted to Haegarda®, the first and only self administered, twice-weekly therapy indicated for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in adolescent and adult patients. Data from the Phase 3 COMPACT trial showed the approved dose of 60 IU/kg reduced the median number of HAE attacks per month by 98% in subjects who had frequent attacks.Health Canada

US FDA

Herpes ZosterHerpes zoster vaccine (non-live recombinant, AS01B adjuvanted) suspension
Shingrix
GlaxoSmithKline
This non-live, recombinant subunit vaccine was approved for the prevention of herpes zoster (shingles) in adults aged ≥50 years. Shingrix is administered intramuscularly (IM) in two doses. In clinical trials, Shingrix showed 89% efficacy in preventing postherpetic neuralgia in patients ≥70 years of age. No loss of efficacy was observed during the 4-year follow-up period.Health Canada
US FDA
Hidradenitis SuppurativaAdalimumab biosimilar
Amgevita™
Amgen
This biosimilar referencing adalimumab (Humira®) was approved in all available indications, including moderate to severe hidradenitis suppurativa.European Commission
Adalimumab-adbm
Cyltezo®
Boehringer Ingelheim
This biosimilar to adalimumab (Humira®), was approved for the treatment of multiple chronic inflammatory diseases, including moderate to severe hidradenitis suppurativa.European Commission
Adalimumab biosimilar
Imraldi®
Samsung Bioepis/Biogen
Imraldi® was approved in the European Union (EU) for all 10 of the current adalimumab (Humira®) indications, including adult and adolescent hidradenitis suppurativa.European Commission
PsoriasisBiosimilar to adalimumab for SC injection
Amgevita™
Amgen
Marketing authorization was granted for Amgevita™, a biosimilar referencing adalimumab (Humira®), in all available indications, including psoriatic arthritis, moderate to severe chronic plaque psoriasis, and moderate to severe hidradenitis suppurativa. This approval also includes certain pediatric inflammatory diseases, including severe chronic plaque psoriasis (≥4 years of age).European Commission
Adalimumab-adbm for SC injection
Cyltezo®
Boehringer Ingelheim
This biosimilar to adalimumab (Humira®), was approved for the treatment of multiple chronic inflammatory diseases, including moderate to severe hidradenitis suppurativa.US FDA

European
Commission

Adalimumab biosimilar for SC injection
Imraldi®
Samsung Bioepis/Biogen
Imraldi® was approved in the EU for all 10 of the current adalimumab (Humira®) indications, including psoriatic arthritis, psoriasis, pediatric plaque psoriasis, and adult and adolescent hidradenitis suppurativa.European Commission
Brodalumab for SC use
US FDA: Siliq™,
Valeant
European Commission: Kyntheum®,
Leo Pharma
Approval was granted to brodalumab, a monoclonal antibody that targets the interleukin (IL)-17 receptor, for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.US FDA

European
Commission

Oral dimethyl fumarate
Skilarence®
Almirall
This new oral formulation of dimethyl fumarate was approved for the treatment of moderate to severe chronic plaque psoriasis. Treatment is indicated for first-line induction and long-term maintenance.European Commission
Guselkumab for SC injection
Tremfya™
MorphoSys/Janssen
Guselkumab was approved for treating adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Guselkumab is a human monoclonal antibody that functions by selectively blocking the cytokine IL-23.European
CommissionHealth CanadaUS FDA
Infliximab-abda for IV injection
Renflexis®
Samsung Bioepis/Merck
Infliximab-abda, a biosimilar referencing infliximab (Remicade®), was approved across all eligible indications, including treatment of psoriatic arthritis and adult plaque psoriasis.Health Canada

US FDA

Infliximab-qbtx for IV injection
Ixifi™
Pfizer
Approval was granted to infliximab-qbtx, a chimeric human-murine monoclonal antibody against tumor necrosis factor, as a biosimilar to infliximab (Remicade®) for all eligible indications of the reference product, including psoriatic arthritis and plaque psoriasis.US FDA
Psoriatic ArthritisAbatacept for IV or SC injection
Orencia®
Bristol-Myers Squibb
Abatacept, a selective T-cell co-stimulation modulator, was approved for the treatment of adults with active psoriatic arthritis (PsA). Abatacept inhibits T-cell activation, thereby blocking the process that triggers the inflammatory cascade implicated in PsA.US FDA
European
Commission
Biosimilar to adalimumab for SC injection
Amgevita™
Amgen
Marketing authorization was granted for Amgevita™ in all available indications, including psoriatic arthritis, moderate to severe chronic plaque psoriasis, and moderate to severe hidradenitis suppurativa. This approval also includes certain pediatric inflammatory diseases,
including severe chronic plaque psoriasis (≥4 years of age).
European Commission
Adalimumab-adbm for SC injection
Cyltezo™
Boehringer Ingelheim
This biosimilar to adalimumab (Humira®), was approved for the treatment of multiple chronic inflammatory diseases, including active psoriatic arthritis and moderate to severe plaque psoriasis. In Europe, Cyltezo® is also approved for hidradenitis suppurativa.US FDA
European
Commission
Adalimumab biosimilar for SC injection
Imraldi®,
Samsung Bioepis/Biogen
Imraldi® was approved in the EU for all 10 of the current adalimumab (Humira®) indications, including psoriatic arthritis, psoriasis, pediatric plaque psoriasis, and adult and adolescent hidradenitis suppurativa.European
Commission
Golimumab for IV use
Simponi Aria®
Janssen Biotech
Golimumab, a fully-human anti-tumor necrosis factor-alpha therapy, was approved for the treatment of adults with active psoriatic arthritis or active ankylosing spondylitis.US FDA
Infliximab-abda
Renflexis®
Samsung Bioepis/Merck
Infliximab-abda, a biosimilar referencing infliximab (Remicade®), was approved across all eligible indications, including treatment of psoriatic arthritis and adult plaque psoriasis.Health Canada
US FDA
Infliximab-qbtx for IV injection
Ixifi™
Pfizer
Approval was granted to infliximab-qbtx, a chimeric human-murine monoclonal antibody against tumor necrosis factor, as a biosimilar to infliximab (Remicade®) for all eligible indications of the reference product, including psoriatic arthritis and plaque psoriasis.US FDA
Ixekizumab for SC injection
Taltz®
Eli Lilly and Company
Ixekizumab was approved for the treatment of adults with active psoriatic arthritis. This is a humanized anti-IL-17 monoclonal antibody that was first approved by the FDA in 2016 for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.US FDA
Tofacitinib tablets
Xeljanz®
Pfizer
Approval was granted to Xeljanz® 5 mg twice daily and Xeljanz® XR extended release 11 mg once daily for the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying
antirheumatic drugs.
US FDA
RosaceaOxymetazoline hydrochloride 1% cream
Rhofade™
Allergan
Approval was granted for oxymetazoline hydrochloride 1% cream to treat persistent facial erythema (redness) associated with rosacea in adults. Oxymetazoline hydrochloride, an alpha-1A-adrenoceptor agonist and a partial agonist at the alpha-2 receptor, diminishes erythema through vasoconstriction.US FDA
Seborrheic KeratosisHydrogen peroxide topical solution
Eskata™
Aclaris Therapeutics
Approval was granted to this hydrogen peroxide topical solution, 40% (w/w) for treating raised seborrheic keratosis (SKs). Treatment is administered through a pen-like applicator directly onto the SK site by a healthcare professional. In Phase 3 trials, patients treated with the solution were more likely to be completely cleared of SKs after 2 treatments vs. placebo.US FDA
Systemic VasculitisMepolizumab for SC injection
Nucala®
GlaxoSmithKline
Expanded use was granted for mepolizumab, a humanized interleukin-5 antagonist monoclonal antibody, to include treating adults with eosinophilic granulomatosis with polyangiitis (EGPA). This new indication provides the first FDA-approved targeted treatment for EGPA, previously known as Churg-Strauss syndrome.US FDA
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approvals issued by US and Canadian drug regulatory agencies, and is sourced from both regulatory and industry news releases.

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