Trade Name: Dupixent^®
Company: Sanofi and Regeneron

Approval Dates/Comments: The US FDA recently approved two new indications for dupilumab, a monoclonal antibody blocking interleukin (IL)-4 and IL-13 receptor signaling. In April 2025, dupilumab was approved for the treatment of adults and adolescents aged ≥12 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment. The approval is based on positive results from Phase 3 trials (LIBERTY-CUPID) demonstrating significant reductions in itch severity and urticaria activity with dupilumab vs. placebo. Additionally, in June 2025, dupilumab was approved for the treatment of adults with bullous pemphigoid. Approval was based on data from the LIBERTY-BP ADEPT Phase 2/3 study, with dupilumab achieving sustained remission and reduced disease severity, as well as demonstrating significant improvements in disease control and itch reduction.

Trade Name: Andembry^®
Company: CSL Behring

Approval Dates/Comments: In June 2025, the FDA approved garadacimab-gxii, a first-in-class, once-monthly, self-injectable treatment for the prevention of hereditary angioedema (HAE) attacks in patients aged ≥12 years. This monoclonal antibody is the only prophylactic HAE therapy that targets factor XIIa, a protein that starts the HAE inflammatory cascade. The approval was based on findings from the pivotal VANGUARD trial, which demonstrated an 87% reduction in frequency of HAE attacks with garadacimab vs. placebo.

Trade Name: Zoryve^®
Company: Arcutis Biotherapeutics

Approval Dates/Comments: In May 2025, the FDA expanded the approved indications of this once-daily, steroid-free, topical selective phosphodiesterase-4 inhibitor to include the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients ≥12 years of age. Regulatory approval was based on findings from the ARRECTOR study, which demonstrated statistically significant improvements in scalp and body psoriasis symptoms with roflumilast foam vs. placebo with significant reductions in scalp and body itch. Treatment was well-tolerated, with adverse events such as headache, diarrhea, and nausea occurring in <4% of patients.

Trade Name: Starjemza^®
Company: Bio-Thera Solutions Hikma Pharmaceuticals

Approval Dates/Comments: In May 2025, the FDA approved this human IL-12 and IL-23 antagonist as a biosimilar referencing the originator product Stelara^® (ustekinumab, Janssen). The approval covers the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease and ulcerative colitis.

Trade Name: Otulfi^®
Company: Fresenius Kabi

Approval Dates/Comments: In May 2025, Otulfi^® became commercially in Canada for treating adult patients with multiple inflammatory diseases including moderate to severe plaque psoriasis and active psoriatic arthritis. Health Canada approval was granted in December 2024. In the US, Otulfi^® (ustekinumab-aauz) was approved by the FDA in September 2024 and became commercially available in March 2025.

Trade Name: Zevaskyn™
Company: Abeona Therapeutics

Approval Dates/Comments: The FDA approved the first and only autologous cell-based gene therapy in April 2025 for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa. Approval was based on the pivotal Phase 3 VIITAL™ study, which demonstrated significant wound healing and pain reduction after a single treatment with a favorable safety profile.

Trade Name: Nduvra™
Company: Organon Canada

Approval Dates/Comments: In April 2025, Health Canada approved this aryl hydrocarbon receptor (AhR) agonist indicated for the once-daily, topical treatment of adults with plaque psoriasis. The mechanism of action of tapinarof involves binding to AhR, a protein implicated in regulating immune responses and skin barrier functions, which leads to suppression of inflammatory cytokines (such as IL-17 and IL-22), reduction of oxidative stress, and modulation of skin barrier protein expression. These combined effects contribute to improved skin function and reduced inflammation. Tapinarof is a non-steroidal agent suitable for long-term use, both as monotherapy or in combination with systemic therapies. Apart from hypersensitivity reactions, there are no known contraindications. Regulatory approval was based on findings from two identical Phase 3 trials (PSOARING 1 and PSOARING 2), which demonstrated statistically significant improvement in Physician Global Assessment (PGA) score of “clear” (PGA=0) or “almost clear” (PGA=1) with a minimum 2-grade improvement vs. vehicle from baseline at week 12. Tapinarof also showed significant improvement in all secondary endpoints vs. vehicle, including ≥75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline at week 12. The majority of adverse effects were mild to moderate and localized to the application site, with the most common being folliculitis, nasopharyngitis, and contact dermatitis. Eligible patients who completed PSOARING 1 or PSOARING 2 were enrolled in PSOARING 3, a Phase 3 Long Term Extension (LTE) study that extended openlabel tapinarof treatment by an additional 40 weeks. In total, patients who received tapinarof in PSOARING 1 or PSOARING 2 and also completed the LTE study received treatment for up to 52 weeks. More than 40% of LTE study patients (n=312/763) achieved complete clearance (PGA=0) at least once. Safety and tolerability were consistent in all three trials. Tapinarof is currently under review by Health Canada for an additional indication to treat atopic dermatitis (AD) in patients ≥2 years of age. In the US, initial FDA approval of tapinarof (Vtama®) was granted in May 2022 for plaque psoriasis, followed by an expanded label to treat AD for patients aged ≥2 years in December 2024.

Trade Name: Omlyclo^®
Company: Celltrion

Approval Dates/Comments: In March 2025, the US FDA approved the first and only biosimilar designated as interchangeable with Xolair® (omalizumab) for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E-mediated food allergy, and chronic spontaneous urticaria.

Trade Name: Zynyz^®
Company: Incyte Corporation

Approval Dates/Comments: Health Canada approved this programmed cell death 1 (PD-1)–blocking antibody in February 2025 for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma not amenable to curative surgery or radiation therapy. This humanized monoclonal antibody specifically targets and binds to PD-1, preventing its interaction with its ligands, PD-L1 and PD-L2. This blockade reactivates T cells, promoting a more robust immune response against cancer cells.

Trade Name: Gomekli™
Company: SpringWorks Therapeutics

Approval Dates/Comments: In February 2025, the US FDA approved the MEK1/2 inhibitor mirdametinib to treat adult and pediatric patients ≥2 years of age with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. This marks the second FDA-approved treatment for NF and the first approved therapy for adults. The regulatory decision was based on results from the Phase 2b ReNeu trial (NCT03962543), a multicenter, open-label study that enrolled 114 patients aged 2 to 17 years (58 adults and 56 children) with inoperable NF1-associated PN causing significant comorbidity. Mirdametinib met the primary endpoint of confirmed objective response rate (ORR), as assessed by blinded independent central review, demonstrating a 41% ORR (N= 24/ 58) in adults and 52% in children (N=29/56). Deep and long-lasting tumor volume reductions were observed. The median best percentage change in target PN volume was -41% (range: -90 to 13%) in adults and -42% (range: -91 to 48%) in children. Eighty-eight percent of adults and 90% of children with a confirmed response experienced a response of at least 12 months duration, and 50% and 48%, respectively, had a response lasting at least 24 months. Patients in both groups also experienced early and sustained significant improvements from baseline in pain and quality of life, as assessed across multiple patient-reported outcome measures. The most common adverse events (>25%) reported in adults treated with mirdametinib were rash, diarrhea, nausea, musculoskeletal pain, vomiting, and fatigue; whereas in children the most common adverse events (>25%) were rash, diarrhea, musculoskeletal pain, abdominal pain, vomiting, headache, paronychia, left ventricular dysfunction, and nausea. More information is available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mirdametinib-adult-and-pediatric-patients-neurofibromatosis-type-1-who-have-symptomatic

Trade Name: Steqeyma^®
Company: Celltrion

Approval Dates/Comments: In December 2024, the FDA approved this biosimilar to the originator product Stelara^® (ustekinumab), for the treatment of multiple chronic inflammatory diseases in adults and pediatric patients. This human monoclonal antibody targeting interleukin (IL)-12 and IL-23 is indicated for the treatment of moderate to severe plaque psoriasis in adult and pediatric patients ≥6 years of age who are candidates for phototherapy or systemic therapy; active psoriatic arthritis in adult and pediatric patients ≥6 years of age; and moderately to severely active Crohn disease or ulcerative colitis in adults.

Trade Name: Opdivo Qvantig™
Company: Bristol Myers Squibb

Approval Dates/Comments: In December 2024, the FDA approved a new dosage form of nivolumab and hyaluronidase-nvhy for subcutaneous (SC) injection across approved adult, solid tumor nivolumab indications as monotherapy, monotherapy maintenance following completion of Opdivo^® (nivolumab) + Yervoy^® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. This approval makes Opdivo Qvantig™ the first and only SC administered PD-1 inhibitor, allowing faster drug delivery for patients to receive this immunotherapy treatment in 3-5 minutes vs. 30 minutes intravenously with Opdivo^®.

Trade Name: Unloxcyt™
Company: Checkpoint Therapeutics

Approval Dates/Comments: The US FDA approved cosibelimab, a human immunoglobulin G1 monoclonal antibody, in December 2024 for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. Cosibelimab is the first and only programmed death ligand-1 (PD-L1)-blocking antibody to receive FDA approval for this indication. It offers a differentiated mechanism of action, binding directly to PD-L1 and inhibiting the PD-L1 interaction with its T cell receptors, PD-1 and B7.1, thereby inducing enhanced, antibody-dependent cell-mediated cytotoxicity. The recommended dosage is 1,200 mg administered as an intravenous infusion over 60 minutes every 3 weeks. Efficacy and safety of cosibelimab were demonstrated in the CK-301-101 (NCT03212404) clinical trial, a multicenter, multicohort, open-label Phase 1 investigation that enrolled 109 patients with mCSCC or laCSCC. All subjects were treated with 800 mg of cosibelimab IV every 2 weeks. The primary endpoints were objective response rate (ORR) and duration of response (DOR), as evaluated by an independent central review (ICR) committee. For patients with locally advanced disease with externally visible target lesions that were not assessable by radiologic imaging, ORR was established by ICR evaluations of digital photography. The ORR was 47% (95% confidence interval [CI], 36%-59%) among 78 patients with mCSCC and 48% (95% CI, 30%- 67%) among 31 patients with laCSCC. Median DOR was not reached (range, 1.4+ to 34.1+ months) in patients with mCSCC and 17.7 months (range, 3.7+ to 17.7 months) in patients with laCSCC. The most common adverse reactions (experienced by at least 10% of patients) included pruritus, edema, fatigue, headache, hypothyroidism, constipation, diarrhea, musculoskeletal pain, rash, nausea, localized infection and urinary tract infection.

Trade Name: Yesintek™
Company: Biocon Biologics

Approval Dates/Comments: The FDA approved ustekinumab-kfce, a biosimilar to the reference product, Stelara® (ustekinumab) in December 2024. Ustekinumab-kfce, a monoclonal antibody, is approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. This approval represents the sixth biosimilar to reference Stelara®.

Trade Name: Emrosi™
Company: Journey Medical

Approval Dates/Comments: In November 2024, the FDA approved hydrochloride extended-release capsules, 40 mg, formerly referred to as DFD-29, for the treatment of inflammatory lesions of rosacea in adults. Approval was based on positive data from two Phase 3 clinical trials for the treatment of rosacea. The Phase 3 clinical trials met all co-primary and secondary endpoints, and subjects completed the 16-week treatment with no significant safety concerns. Emrosi™ demonstrated statistically significant superiority over both the current standard-of-care treatment, Oracea® 40 mg capsules, and placebo for Investigator’s Global Assessment treatment success, as well as the reduction in total inflammatory lesion count in both trials.

Trade Name: Opzelura®
Company: Incyte Biosciences

Approval Dates/Comments: In October 2024, Health Canada approved ruxolitinib cream 1.5%, a non-steroidal topical Janus kinase (JAK) inhibitor, for the treatment of mild to moderate atopic dermatitis in patients ≥12 years of age whose disease is not adequately controlled with conventional topical prescription therapies (i.e., topical corticosteroids and topical calcineurin inhibitors) or when those therapies are inadvisable. Additionally, Health Canada approved a second indication for ruxolitinib to treat nonsegmental vitiligo in adult and pediatric patients ≥12 years of age.

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Roflumilast foam 0.3%

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Clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% fixed-dose topical gel

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Lebrikizumab-lbkz

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Ustekinumab-srlf

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Ustekinumab-aauz

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Ustekinumab biosimilar

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Trade Name: Nemluvio®
Company: Galderma

Approval Dates/Comments: The US FDA approved nemolizumab, a first-in-class interleukin-31 (IL-31) blocker, in August 2024 for the treatment of adults with prurigo nodularis. This humanized monoclonal antibody specifically targets the IL-31 receptor, a key cytokine that drives inflammation. Regulatory approval
was based on positive results from Phase 3 OLYMPIA clinical trials, in which nemolizumab demonstrated significant and clinically meaningful reductions in itch and skin nodules at Week 16, with rapid improvements in itch observed as early as Week 4. It is currently under FDA review for treating atopic dermatitis.

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Denileukin diftitox-cxdl IV use

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Deuruxolitinib phosphate tablets

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Roflumilast cream

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Ustekinumab-ttwe SC/IV injection

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Sofpironium gel, 12.45%

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Ustekinumab biosimilar

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Lebrikizumab SC injection

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Trade Name: Cyltezo®
Company: Boehringer Ingelheim

Approval Dates/Comments: In May 2024, the US FDA approved a citrate-free, highconcentration formulation of the interchangeable adalimumab biosimilar Cyltezo® to treat multiple chronic inflammatory diseases including psoriasis and psoriatic arthritis. The high-concentration preparation of this TNF-α inhibitor is available in a 100 mg/mL dose and comes in a pre-filled syringe or autoinjector and sold at a 5% discount to the branded reference product. An unbranded version of Cyltezo® is also available at an 81% discount to Humira®. A low-concentration, 50 mg/mL version of the biosimilar has been on the market since July 2023. This latest FDA approval of this high-concentration, citrate-free version of adalimumab-adbm, makes it the 5th high-concentration biosimilar referencing the originator biologic therapy Humira® (adalimumab) to be approved in the US, following Hadlima™, Hyrimoz®, Yuflyma®, and Simlandi®. High-concentration adalimumab comprises about 80% of total adalimumab prescriptions. Of the products with a high-concentration formulation, Cyltezo®, Hadlima™, and Hyrimoz® are the only ones that offer a low-concentration formulation.¹ In 2023 alone, 9 adalimumab biosimilars became commercially available: Amjevita™ (Amgen), Cyltezo® (Boehringer Ingelheim), Hadlima™ (Organon/ Samsung Bioepis), Hulio® (Biocon Biologics), Yuflyma® (Celltrion), Yusimry™ (Coherus Biosciences), Abrilada™ (Pfizer), Hyrimoz® (Sandoz), and Idacio® (Fresenius Kabi); with Simlandi® (Alvotech/Teva) being the 10th and most recent approval in 2024.²

1. 1. Jeremias S. FDA approves high-concentration Cyltezo. The Centre for Biosimilars. May 1, 2024. Available from: https://www.centerforbiosimilars.com/view/fda-approves-high-concentration-cyltezo
   2. Jeremias S. FDA approves 10th adalimumab biosimilar, Simlandi. The Centre for Biosimilars. February 24, 2024. Available from: https://www.centerforbiosimilars.com/view/fda-approves-tenth-adalimumab-biosimilar-simlandi

Trade Name: Cosentyx®
Company: Novartis Pharmaceuticals

Approval Dates/Comments: In May 2024, Health Canada approved an extension to the authorized indications for secukinumab to treat adults with moderate to severe hidradenitis suppurativa (HS) (acne inversa) who have responded inadequately to conventional systemic HS therapy. Secukinumab is the only regulatory approved fully human biologic that directly inhibits interleukin-17A (IL-17A), a cytokine implicated in the inflammation associated with HS. Approval is based on two Phase 3 trials (SUNSHINE [NCT03713619] and SUNRISE [NCT03713632]), in which a higher proportion of HS patients receiving secukinumab 300 mg either every 2 weeks or every 4 weeks achieved HiSCR50 compared with placebo. In both the SUNSHINE and SUNRISE studies, which evaluated secukinumab across 16-week (vs. placebo) and 52-week treatment periods, the onset of action occurred as early as Week 2. Efficacy improved progressively to Week 16 and was observed up to Week 52.

Trade Name: Spevigo™
Company: Boehringer Ingelheim

Approval Dates/Comments: In March 2024, the FDA expanded the approval of spesolimab to include the treatment of generalized pustular psoriasis (GPP) in adult and pediatric patients ≥12 years of age and weighing ≥40 kg. The original approval was for treatment of GPP flares in adults. Spesolimab is a novel, humanized selective IgG1 antibody that binds to interleukin-36 receptor (IL-36R), a central signaling pathway in the immune system implicated in the pathogenesis of GPP. The basis of this recent regulatory decision was the positive findings from the EFFISAYIL® 2 clinical trial, a 48-week clinical trial demonstrating spesolimab significantly reduced the risk of GPP flares by 84% vs. placebo. In the trial, no flares were observed after week 4 of subcutaneous spesolimab therapy in the high-dose group. Spesolimab treatment was associated with an increased incidence (≥9 cases per 100 patient-years) of injection site reaction, urinary tract infection, arthralgia, and pruritus.

Trade Name: Letybo™
Company: Hugel

Approval Dates/Comments: In February 2024, the FDA approved the injectable neurotoxin letibotulinumtoxinA-wlbg, a 900 kDa botulinum toxin typeA, to temporarily improve the appearance of moderate to severe glabellar lines in adults.

Trade Name: Bimzelx®
Company: UCB Canada Inc.

Approval Dates/Comments: Health Canada approved a new indication for bimekizumab in February 2024 to include adults with active psoriatic arthritis (PsA). Bimekizumab is the first and only biologic therapy that directly inhibits both interleukin (IL)-17A and IL-17F to be approved in Canada. This regulatory decision was supported by data from two Phase 3 clinical trials (BE OPTIMAL and BE COMPLETE) demonstrating treatment with bimekizumab resulted in significant improvement across key disease severity indicators in PsA. The original approval was for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Trade Name: Xolremdi™
Company: X4 Pharmaceuticals

Approval Dates/Comments: The US FDA approved oral mavorixafor in April 2024 as the first targeted treatment for the rare, inherited immunodeficiency disease WHIM syndrome – characterized by warts, hypogammaglobulinemia, infections and myelokathexis. Mavorixafor is a small-molecule selective CXCR4 receptor antagonist designed to mobilize white blood cells such as neutrophils, lymphocytes and monocytes from the bone marrow into the peripheral blood circulation to improve immune deficiencies. Treatment is approved for patients ≥12 years of age.

Trade Name: Selarsdi™
Company: Alvotech/Teva Pharmaceutials

Approval Dates/Comments: In April 2024, the FDA approved ustekinumab-aekn, a biosimilar to the branded reference product, Stelara® (ustekinumab, Johnson & Johnson). Approved indications include treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients ≥6 years of age. However, Selarsdi™ is not approved for Crohn’s disease and ulcerative colitis. This regulatory decision is based on results of the Phase 3 AVT04-GL-301 study, which demonstrated comparable efficacy and safety in patients with moderate-to-severe chronic plaque-type psoriasis, including equivalent immunogenicity profile to Stelara®.

Trade Name: Spevigo™
Company: Boehringer Ingelheim

Approval Dates/Comments: In March 2024, the FDA expanded the approval of spesolimab to include the treatment of generalized pustular psoriasis (GPP) in adult and pediatric patients ≥12 years of age and weighing ≥40 kg. The original approval was for treatment of GPP flares in adults. Spesolimab is a novel, humanized selective IgG1 antibody that binds to interleukin-36 receptor (IL-36R), a central signaling pathway in the immune system implicated in the pathogenesis of GPP. The basis of this recent regulatory decision was the positive findings from the EFFISAYIL® 2 clinical trial, a 48-week clinical trial demonstrating spesolimab significantly reduced the risk of GPP flares by 84% vs. placebo. In the trial, no flares were observed after week 4 of subcutaneous spesolimab therapy in the high-dose group. Spesolimab treatment was associated with an increased incidence (≥9 cases per 100 patient-years) of injection site reaction, urinary tract infection, arthralgia, and pruritus.

Trade Name: Letybo™
Company: Hugel

Approval Dates/Comments: In February 2024, the FDA approved the injectable neurotoxin letibotulinumtoxinA-wlbg, a 900 kDa botulinum toxin typeA, to temporarily improve the appearance of moderate to severe glabellar lines in adults.

Trade Name: Bimzelx®
Company: UCB Canada Inc.

Approval Dates/Comments: Health Canada approved a new indication for bimekizumab in February 2024 to include adults with active psoriatic arthritis (PsA). Bimekizumab is the first and only biologic therapy that directly inhibits both interleukin (IL)-17A and IL-17F to be approved in Canada. This regulatory decision was supported by data from two Phase 3 clinical trials (BE OPTIMAL and BE COMPLETE) demonstrating treatment with bimekizumab resulted in significant improvement across key disease severity indicators in PsA. The original approval was for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Trade Name: Simlandi®
Company: Alvotech/Teva

Approval Dates/Comments: In February 2024, the US FDA approved the first highconcentration, citrate-free and interchangeable Humira® biosimilar. Sanctioned indications include plaque psoriasis, psoriatic arthritis, and hidradenitis suppurativa.

Trade Name: LUT014
Company: Lutris Pharma

Approval Dates/Comments: The FDA granted an Orphan Drug designation in February 2024 to this novel topically applied B-Raf inhibitor for the treatment of epidermal growth factor receptor (EGFR) inhibitor-induced acneiform lesions.

Trade Name: Amtagvi™
Company: Iovance Biotherapeutics

Approval Dates/Comments: In February 2024, the FDA approved the first cellular therapy indicated for the individualized treatment of adult patients with unresectable, metastatic melanoma previously treated with other therapies (i.e., a PD-1 blocking antibody and, if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor). Lifileucel is a tumor-derived autologous T cell immunotherapy. Prior to treatment, a portion of the patient’s tumor tissue is surgically removed, T cells are separated from the tumor tissue, further manufactured and infused back into the patient. Upon detection, the immune system creates TIL cells that identify and destroy cancer cells.

Trade Name: Zelsuvmi™
Company: Ligand Pharmaceutical

Approval Dates/Comments: The FDA approved this topical nitric oxide releasing agent in January 2024 for treating molluscum contagiosum in patients aged ≥1 year. This is the first and only topical prescription medication for molluscum that can be administered at home by a patient, family member or caregiver.

Trade Name: DermaSensor™
Company: DermaSensor Inc.

Approval Dates/Comments: In January 2024, FDA device clearance was granted to DermaSensor, the first AI-powered tool to diagnose skin cancer, including melanoma, basal cell carcinoma, and squamous cell carcinoma, at the point of testing and noninvasively in patients aged ≥40 years. This wireless, handheld, prescription device uses spectroscopy technology to examine lesions at cellular and subcellular levels, then analyze their characteristics using an FDA-cleared algorithm. The device demonstrated 96% sensitivity, with negative results having a 97% chance of being benign.

Trade Name: ACAM2000®
Company: Emergent

Approval Dates/Comments: In December 2023, the ACAM2000® (Vaccinia Virus, live) vaccine was authorized by Health Canada for active immunization against smallpox disease for persons aged ≥16 years determined to be at high risk for infection.

Trade Name: Tembexa®
Company: Emergent

Approval Dates/Comments: Health Canada approved brincidofovir (tablets & oral suspension) in December 2023 for the treatment of human smallpox disease in adult and pediatric patients, including neonates.

Trade Name: Litfulo™
Company: Pfizer

Approval Dates/Comments: In November 2023, Health Canada approved this dual JAK3 + TEC family kinase inhibitor for the once-daily, oral treatment of adults and adolescents aged ≥12 years with severe alopecia areata. Ritlecitinib works by inhibiting signaling pathways of cytokines and cytolytic activity of T cells implicated in the pathogenesis of alopecia areata.

Trade Name: Jamteki™
Company: Jamp Pharma

Approval Dates/Comments: In November 2023, Health Canada approved the first biosimilar of ustekinumab (reference biologic drug Stelara®, Janssen) for the treatment of plaque psoriasis and psoriatic arthritis.

Trade Name: Zoryve®
Company: Arcutis Biotherapeutics

Approval Dates/Comments: In December 2023, the US FDA approved roflumilast 0.3% topical foam for the treatment of seborrheic dermatitis (SD) in individuals ≥9 years of age. Roflumilast is a once-daily topical, selective phosphodiesterase type 4 inhibitor – it is the first drug approved for SD with a new mechanism of action in over 2 decades. This steroid-free foam is suitable for chronic use anywhere on the body, including hair-bearing body areas such as the scalp, face and trunk which can be more susceptible to SD. Regulatory approval was based on positive data from the pivotal phase 3 trial, STRATUM (NCT04973228). The primary efficacy endpoint was Investigator Global Assessment (IGA) success (IGA of clear or almost clear + a ≥2-grade improvement from baseline) at week 8. Almost 80% of patients treated with roflumilast achieved IGA success compared to 58% of vehicle-treated patients, with early disease improvement observed as early as week 2. About 50% of individuals reached complete clearance at week 8.

Trade Name: Filsuvez®
Company: Chiesi Global Rare Diseases

Approval Dates/Comments: The FDA approved birch triterpenes (derived from birch bark) topical gel in December 2023 for the treatment of partial thickness wounds in patients aged ≥6 months with junctional epidermolysis bullosa (JEB) and dystrophic epidermolysis bullosa. This is the first approved treatment for wounds associated with JEB.

Trade Name: Qtorin™
Company: Palvella Therapeutics

Approval Dates/Comments: In November 2023, the FDA granted Breakthrough Therapy designation to Qtorin™ for the treatment of microcystic lymphatic malformations (microcystic LMs). This novel topical formulation is also currently under development for other serious, functionally debilitating skin diseases (e.g., pachyonychia congenita and the prevention of basal cell carcinomas [BCCs] in Gorlin Syndrome) that are driven by the overactivation of the mammalian target of rapamycin (mTOR) pathway.

Trade Name: Bimzelx®
Company: UCB

Approval Dates/Comments: The FDA approved bimekizumab-bkzx in October 2023 for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Bimekizumab is the first and only approved psoriasis treatment designed to selectively inhibit two key cytokines driving inflammatory processes – interleukin 17A and interleukin 17F. Regulatory approval was supported by data from three Phase 3, multicenter, randomized, placebo and/or active comparatorcontrolled trials (BE READY, BE VIVID and BE SURE).

Trade Name: Cosentyx®
Company: Novartis

Approval Dates/Comments: In October 2023, the FDA expanded the label of secukinumab to include treating moderate to severe hidradenitis suppurativa (HS) in adults. Secukinumab is the only FDA-approved fully human biologic that directly inhibits interleukin-17A, a major cytokine implicated in the inflammation of HS.

Trade Name: Wezlana™
Company: Amgen

Approval Dates/Comments: The FDA approved ustekinumab-auub (Wezlana™) in October 2023 as the first biosimilar to reference ustekinumab (Stelara®) for multiple inflammatory diseases including adults and children ≥6 years of age with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and patients ≥6 years of age with active psoriatic arthritis.