Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI™ (ustekinumab-aekn) with Stelara® (ustekinumab)

Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI™ (ustekinumab-aekn) with Stelara® (ustekinumab)

The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) in all presentations matching the reference product, effective as of April 30, 2025SELARSDI is approved for all indications matching the reference productSELARSDI is indicated for…

FDA Grants Ustekinumab-Aekn Interchangeability Designation for Stelara

Selarsdi is interchangeable for all indications of ustekinumab, including treatment of psoriatic arthritis, plaque psoriasis, Crohn disease, and ulcerative colitis.

FDA approves Selarsdi as interchangeable with Stelara

Teva and Alvotech have announced receipt of the US FDA approval to Selarsdi injection for use as an interchangeable with Stelara.

Ustekinumab-aekn Now Interchangeable With Reference for PsA, PsO, CD, UC

SELARSDI gains FDA interchangeability with Stelara, enhancing access to affordable treatments for psoriatic arthritis, psoriasis, Crohn's, and ulcerative colitis.

The FDA has determined that the drug launched by Teva and Allotech is interchangeable with the original biologic drug Stelara • Teva's stock has been trending positively recently, amid expectations that its financial reports published on Wednesday will be positive

Teva's drug, called SELARSDI, received marketing approval a year ago, but only with a doctor's prescription; the original drug enjoys sales of $1.8 billion; Teva will publish first-quarter results the day after tomorrow