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Pharmacy Bulletin

Pharmacy Bulletin

We share important prescription drug information to help you stay informed about updates concerning particular prescription medicines.

VativoRx Bottle update

FDA Approves Fifth Biosimilar to Stelara

On Oct. 11, 2024, Dong-A ST, an Accord Biopharma partner, announced that the U.S. Food and Drug Administration (FDA) approved Imuldosa (ustekinumab-srlf), another biosimilar to Janssen’s Stelara®. By inhibiting interleukins 12 and 23 (IL-12 and IL-23), ustekinumab interrupts processes involved in chronic inflammation. It is indicated to treat patients with autoimmune diseases like plaque psoriasis, psoriatic arthritis Crohn’s disease (CD), and ulcerative colitis (UC). Doses are based on the patient’s weight. For psoriatic conditions, two initial subcutaneous (SC) doses are given one month apart, and then treatment switches to one SC injection every three months. Patients who have CD or UC receive one intravenous (IV) infusion followed by SC injections at two-month intervals. Patients who use ustekinumab may be more susceptible to acquiring infections, including tuberculosis (TB), and of developing cancer. Accord disclosed that it had reached a settlement with Janssen that permits Accord to launch its biosimilar no later than May 15, 2025, and the prescribing information will be available at that time.  This is the fifth biosimilar to Stelara that is all expected to launch early next year, including FDA-approved Wezlana (ustekinumab-auub – Amgen), Selarsdi (ustekinumab-aekn – Alvotech/Teva), Pyzchiva (ustekinumab-ttwe – Sandoz) and Otulfi (ustekinumab-aauz – Fresenius Kabi/ Formycon). It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete.