The FDA recently approved yet another biosimilar to Stelara. Starjemza (ustekinumab-hmny) is from Bio-Thera Solutions and Hikma Pharmaceuticals. The lineup of the previously approved Stelara biosimilars follows… Selarsdi (ustekinumab-aekn), Pyzchiva (ustekinumab-ttwe), Otulfi (ustekinumab-aauz), Imuldosa (ustekinumab-srlf), Wezlana (ustekinumab-auub), Yesintek (ustekinumab-kfce) and Steqeyma (ustekinumab-stba), the last of which was approved earlier this year.
Starjemza 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.
Bio-Thera and Hikma did not release pricing at the time of approval. By way of reference, the list price of Stelara is $13,836 for one month supply. Earlier Stelara biosimilars have projected pricing to come in at a 20% discount to Stelara.
Bio-Thera and Hikma did not specify details for distribution.
CLICK HERE for prescribing information.
FDA Approves Ustekinumab Biosimilar Starjemza
CLICK HERE to read the company press release
