Though earlier clinical trials have suggested ustekinumab (Stelara®) may be an effective therapy for the treatment of systemic lupus erythematosus, the latest research findings call the drug’s ...

Please provide your email address to receive an email when new articles are posted on . Amgen will be allowed to sell its Stelara biosimilar “no later than Jan. 1, 2025.” Whether the development with ...

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 ...

Alvotech recently submitted a Citizen Petition to the FDA requesting that the agency refuse to license any ustekinumab biosimilar as interchangeable with STELARA if it is manufactured using a Chinese ...

On August 7, 2023, Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson (“J&J”) in the United States relating to FYB202, a proposed ustekinumab ...

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) today announced the availability of SELARSDI™ (ustekinumab-aekn) ...

Fresenius Kabi, an Operating Company of Fresenius, and a leading provider of essential medicines and medical technologies, announced today it has introduced a new presentation of Otulfi® ...

RALEIGH, N.C., Aug. 18, 2025 /PRNewswire/ -- Accord BioPharma, Inc., the specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology ...

* The first primary endpoint was clinical remission (per CDAI) at week 24, and the second primary endpoint was endoscopic remission (per SES-CD) at week 48. Non-inferiority was met for the first ...

SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva SELARSDI is expected to be marketed in the ...