…………catching up on FDA approvals
The FDA has approved a new therapy, Imuldosa (ustekinumab-srlf) from Accord BioPharma Inc., as a biosimilar to Janssen Biotech’s Stelara. Imuldosa is available in a subcutaneous form as well as an infusible.
The approval of Imuldosa marks the fifth ustekinumab approval for the US.
Imuldosa is slated to launch in May 2025 according to sources.
Imuldosa 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.
It is noted that 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 Imuldosa did not receive a Black Box warning there are a number of warnings and precautions consistent with the other previously approved Stelara biosimilars.
Pricing and distribution plans were not announced.
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