FDA Approves Fourth Biosimilar to Stelara
The U.S. Food and Drug Administration (FDA) approved Fresenius Kabi and Formycon’s Otulfi™ (ustekinumab-aauz), a Stelara® (ustekinumab – Johnson & Johnson Innovative Medicine) biosimilar, on Sept. 30, 2024. By inhibiting interleukins 12 and 23 (IL-12 and IL-23), ustekinumab interrupts processes involved in chronic inflammation. Otulfi is indicated to treat adults who have moderately to severely active Crohn’s disease (CD) or ulcerative colitis (UC). In addition, it’s also approved for patients as young as six years old who have psoriatic arthritis (PsA) or plaque psoriasis that is amenable to phototherapy or systemic therapy. 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. Otulfi will be available as 45mg/0.5mL and 90mg/mL single-dose prefilled syringes for SC injection and 130mg/26mL (5mg/mL) single-dose vials for IV infusion. Patients who use ustekinumab may be more susceptible to acquiring infections, including tuberculosis (TB), and of developing cancer. Otulfi will be marketed in the U.S. under a settlement agreement that allows its release for sale no later than Feb. 22, 2025. Several biosimilars to Stelara are expected to launch early next year, including FDA-approved Wezlana™ (ustekinumab-auub – Amgen), Selarsdi™ (ustekinumab-aekn – Alvotech/Teva) and Pyzchiva™ (ustekinumab-ttwe – Sandoz). Prescribing information is here.
First Generic for Sandostatin LAR Depot Launched
Teva Pharmaceuticals announced the launch of the first and only generic to Novartis’ Sandostatin® LAR Depot (octreotide acetate for injectable suspension) on Oct. 1, 2024. Octreotide acetate for injectable suspension is indicated for the treatment of acromegaly, a disorder caused by an overproduction of growth hormone, severe diarrhea and flushing in carcinoid syndrome, a complication of certain cancers and profuse watery diarrhea associated with vasoactive intestinal peptide (VIP)-secreting tumors. Teva has not released pricing information for the new generic. Sandostatin LAR Depot had annual sales of $826 million as of July 2024. Here is the prescribing information.
Extended Indication for Opdivo
On Oct. 3, 2024, Bristol Myers Squibb announced that Opidvo® (nivolumab) expanded its non-small cell lung cancer (NSCLC) indication to be used with chemotherapy before surgery and as monotherapy after surgery in patients with resectable NSCLC who have no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. Previously, it was only approved for pre-surgery therapy or neoadjuvant therapy for early-stage NSCLC. A programmed death receptor-1 (PD-1)-blocking antibody, Opdivo has indications for several other cancers, including some types of melanoma, small cell lung cancer (SCLC), esophageal squamous cell carcinoma (ESCC), specific kinds of renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), urothelial carcinoma, metastatic colorectal cancer (CRC) and classic Hodgkin lymphoma. For neoadjuvant treatment, the recommended Opdivo dosage is 360mg every three weeks and 480mg every four weeks for adjuvant treatment. Keytruda (Merck) and Imfinzi (AstraZeneca), other PD-1s, are approved for this indication; however, Opidvo is the only to be approved for both resectable NSCLC and perioperative treatment. Here is the prescribing information.