…………catching up on FDA approvals
The FDA has approved a new therapy, Wezlana (ustekinumab-auub) from Amgen, Inc., as a biosimilar to Janssen Biotech’s Stelara. Wezlana is available in a subcutaneous form as well as an infusible. . Wezlana joins the ranks of only a handful of biosimilars to also earn the title if interchangeability with the reference product.
Wezlana is indicated for—–
Adult patients with:
- moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy,
- active psoriatic arthritis;
- moderately to severely active Crohn’s disease; and
- moderately to severely active ulcerative colitis.
Pediatric patients 6 years of age and older with:
- moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and
- active psoriatic arthritis.
Prescribing information specifies subcutaneous dosing and administration for Psoriasis and Psoriatic Arthritis while specifying intravenous dosing instructions for Crohn’s Disease and Ulcerative Colitis.
CLICK HERE for prescribing information
While Wezlana did not receive a Black Box warning there are a number of warnings and precautions.
Amgen intends to launch Wezlana in early 2025 when Stelara’s patent exclusivity expires. As such, pricing and distribution plans were not announced.
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