Trade Name: Yuflyma™
Company: Celltrion Healthcare
Approval Dates/Comments: In December 2021, Health Canada approved this fully human anti-tumor necrosis factor-alpha monoclonal antibody. Yuflyma™ is a high-concentration (100 mg/mL), low-volume, citrate-free, and latex-free biosimilar to Humira® (adalimumab). It is approved across all 10 intended indications for treating multiple chronic inflammatory diseases, including plaque psoriasis, psoriatic arthritis, and hidradenitis suppurativa.
Trade Name: Simlandi™
Company: Alvotech/JAMP Pharma
Approval Dates/Comments: In January 2022, Health Canada approved this high-concentration, citrate-free biosimilar to Humira® (adalimumab) at doses of 40 mg/0.4 mL and 80 mg/0.8 mL. The 80 mg/0.8 mL dose will reduce the number of starting injections by 50% for the patients requiring it. Sanctioned indications include plaque psoriasis, psoriatic arthritis, and hidradenitis suppurativa.
Trade Name: Cibinqo®
Approval Dates/Comments: In January 2022, the US FDA approved abrocitinib, an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for treating adults with refractory, moderate-to-severe atopic dermatitis (AD) not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Abrocitinib was approved at doses of 100 mg and 200 mg, with the 200 mg dose being recommended for patients who do not respond to the 100 mg dose. Additionally, a 50 mg dose was approved to treat moderate-to-severe AD specifically in patients with moderate renal impairment, certain patients receiving treatment with inhibitors of cytochrome P450 (CYP) 2C19, or patients who are known or suspected to be poor metabolizers of CYP2C19. For patients with moderate renal impairment who are not responding to 50 mg once daily, 100 mg once daily may also be prescribed.
Trade Name: Rinvoq®
Approval Dates/Comments: The FDA expanded the approval of this oral JAK1 inhibitor in January 2022 to include the treatment of moderate-to-severe atopic dermatitis in adults and children ≥12 years of age whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended. Rinvoq® 15 mg once daily can be initiated in adults and children ≥12 years of age weighing at least 40 kg. In patients <65 years of age who do not achieve an adequate response, the dose may be increased to 30 mg once daily.
Risankizumab-rzaa SC injection
Trade Name: Skyrizi®
Approval Dates/Comments: In January 2022, the FDA expanded the approval of this humanized monoclonal antibody targeting interleukin 23A to include the treatment of adults with active psoriatic arthritis (PsA). This decision is supported by data from two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, which investigated the efficacy and safety of risankizumab in adults with active PsA, including those who had an inadequate response or were intolerant to biologic therapy and/or nonbiologic disease-modifying antirheumatic drugs.
HA-based dermal filler
Trade Name: Juvéderm® Volbella® XC
Company: AbbVie/ Allergan Aesthetics
Approval Dates/Comments: The FDA granted a new indication for this hyaluronic acid (HA)-based injectable dermal filler in February 2022 for improvement of infraorbital hollows in adults aged >21 years. This approval carries the requirement that Allergan Aesthetics must provide a product training program for all potential providers, which includes facial anatomy and considerations for safe injection in this area, as well as identification and management of complications.