Adalimumab-adbm for SC use
Trade Name: Cyltezo®
Company: Boehringer Ingelheim
Approval Dates/Comments: In October 2021, the US FDA approved this biologic agent as the first interchangeable (may be substituted for) monoclonal antibody with Humira® (adalimumab). Cyltezo® was initially sanctioned in 2017 for use in treating multiple chronic inflammatory diseases, but this latest approval designates this biosimilar as interchangeable across all approved indications.
Tralokinumab for SC use
Trade Name: Adtralza® (in Canada)
Tralokinumab-ldrm for SC use
Trade Name: Adbry™ (in US)
Company: Leo Pharma
Approval Dates/Comments: Tralokinumab, a human interleukin-13-neutralizing monoclonal antibody, was approved by Health Canada in October 2021 and in December 2021 by the US FDA for treating moderate/severe atopic dermatitis in adults. It is indicated for use in adults aged ≥18 years whose disease cannot be sufficiently controlled through topical prescription drugs alone or when such therapies are inadvisable. It is safe to use with or without topical corticosteroids.
Melanoma vaccine for IV use
Trade Name: BNT111
Approval Dates/Comments: In November 2021, the FDA granted Fast Track Designation for this investigational cancer immunotherapy for the potential treatment of advanced melanoma. BNT111 utilizes a fixed combination of mRNA-encoded, tumor-associated antigens to trigger a robust and targeted immune response against cancer cells. It is currently being investigated in a Phase II trial in patients with anti-PD-1 refractory/relapsed unresectable stage III or IV melanoma.
Adalimumab-aqvh for SC use
Trade Name: Yusimry™
Company: Coherus BioSciences
Approval Dates/Comments: In December 2021, the FDA approved this biosimilar referencing adalimumab (Humira®) across eligible indications including plaque psoriasis and psoriatic arthritis. Like other Humira® biosimilars, Yusimry™ will not be available for the US market until July 1, 2023, when the patents protecting the originator drug will expire.
Trade Name: Otezla®
Approval Dates/Comments: In December 2021, the FDA approved apremilast for the treatment of adult patients, regardless of severity level, with plaque psoriasis who are candidates for phototherapy or systemic therapy. With this expanded indication, apremilast is now the first and only oral treatment approved in adults with plaque psoriasis across all severities, including mild, moderate and severe.
Pembrolizumab for IV use
Trade Name: Keytruda®
Approval Dates/Comments: In December 2021, the FDA approved this anti-PD-1 therapy for the adjuvant treatment of patients aged ≥12 years with stage IIB or IIC melanoma following complete resection. The FDA also expanded the indication for pembrolizumab as adjuvant treatment for stage III melanoma following complete resection to include pediatric patients ≥12 years of age.
Secukinumab for SC use
Trade Name: Cosentyx®
Approval Dates/Comments: In December 2021, the FDA approved secukinumab for treating active enthesitis-related arthritis (ERA) in patients aged ≥4 years, and active psoriatic arthritis (PsA) in patients aged ≥2 years. Secukinumab is the only biologic approved for both ERA and PsA in pediatric patients in the US.
Trade Name: Tpoxx®
Company: SIGA Technologies
Approval Dates/Comments: Health Canada approved oral tecovirimat in December 2021 as an extraordinary use new drug. Specifically, the agency authorized the use of tecovirimat, an orthopoxvirus-specific antiviral, for treating human smallpox disease caused by the variola virus. FDA approval was gained in July 2018.
Trade Name: Rinvoq®
Approval Dates/Comments: The FDA approved this oral Janus kinase 1 (JAK1)-selective inhibitor in December 2021 for the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.