Adalimumab-adbm for SC injection

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. 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

Secukinumab for SC injection

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.


Tirbanibulin 1% ointment

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.


LetibotulinumtoxinA-wlbg IM use

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.


Bimekizumab SC use

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.