Interchangeable Status for Multiple Stelara Biosimilars

Effective April 30, 2025, Alvotech and Teva announced that previously US Food and Drug Administration (FDA) approved Selarsdi^™ (ustekinumab-aekn) is now interchangeable with reference biologic Stelara (ustekinumab – Genentech). The first approved biosimilar to Stelara, Wezlana^™ (ustekinumab-auub – Amgen) is also interchangeable. While not officially announced, Pyzchiva^™ (ustekinumab-ttwe – Sandoz/Samsung Bioepis), Otulfi^™ (ustekinumab-aauz – Fresenius Kabi/Formycon), Yesintek^™ (ustekinumab-kfce – Biocon) and Steqeyma^™ (ustekinumab-stba – Celltrion) appear to have also been granted interchangeability status as of April 30, 2025. In states where pharmacy regulations allow substitution, it can be dispensed instead of Stelara without contacting the prescriber. Prescribing information for all can be found on the Drugs@FDA drug database at www.fda.gov.

Low-Dose Chlorthalidone, HemiClor, Approved

On May 6, 2025, the FDA approved PRM Pharma’s HemiClor^™ (chlorthalidone) 12.5mg tablets for the treatment of hypertension in adults. A thiazide-like diuretic, chlorthalidone, has been used in hypertension management since 1960. Current hypertension guidelines recommend a starting dose of chlorthalidone 12.5mg, however, only 25mg and 50mg tablets have been available until now. Doses may be doubled every two to four weeks as needed based on blood pressure response, up to a maximum of 100mg once daily. Adverse effects like hypokalemia and hyperuricemia are dose dependent. Launch is expected this month, and the cost is not yet known. Prescribing information is here.

First Aptiom Generic Launched

On May 7, 2025, Lupin announced both FDA approval and launch of eslicarbazepine acetate 200mg, 400mg, 600mg, and 800mg tablets, the first generic to reference Sumitomo’s Aptiom^®. Lupin’s generic is eligible for 180 days of exclusivity and is indicated for the treatment of partial-onset seizures in patients four years of age and older. As of March 2025, annual sales for eslicarbazepine were approximately $395 million. Full prescribing information will be available on the Drugs@FDA drug database at www.fda.gov.

Generic Isentress Approved

Lupin announced FDA approval of raltegravir tablets, 600mg, on May 8, 2025. Indicated with other antiretroviral agents for the treatment of HIV infection in adults and pediatric patients weighing at least 40kg, raltegravir is the reference drug to Merck’s Isentress^® HD tablets, 600mg. As the first-to-file, Lupin is eligible for 180 days of generic drug exclusivity. As of March 2025, annual sales of raltegravir were approximately $34 million. Full prescribing information will be available on the Drugs@FDA drug database at www.fda.gov.