Adalimumab-ryvk for SC injection

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.


B-Raf inhibitor gel

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.


Lifileucel tumorinfiltrating lymphocyte (TIL) suspension for IV use

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.


Berdazimer topical gel, 10.3%

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.


Artificial intelligencepowered skin cancer diagnostic tool

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.


Smallpox vaccine

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.


Oral brincidofovir

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.


Ritlecitinib tosylate capsules

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.


Ustekinumab biosimilar

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.

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