The FDA recently approved a biosimilar, Yesintek (Ustekinumab-kfce) from Biocon Biologics Ltd, as a biosimilar to the reference product, Stelara (Ustekinumab).
This approval is the newest biosimilar approval for a Stelara competitor.
The currently approved biosimilars include — Selarsdi (ustekinumab-aekn), Pyzchiva (ustekinumab-ttwe), Otulfi (ustekinumab-aauz), Imuldosa (ustekinumab-srlf), Wezlana (ustekinumab-auub), and Yesintek (ustekinumab-kfce).
Yesintek 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
The company plans its product launch in the United States later in February following a settlement with J&J. Distribution details were not announced.
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