Medicare and its beneficiaries are paying significantly more for Stelara, Johnson & Johnson’s (NYSE:JNJ) popular biologic drug used to treat autoimmune diseases when obtained through pharmacies rather ...

Teva Pharmaceuticals and Alvotech have announced that the US Food and Drug Administration (FDA) has approved the Selarsdi (ustekinumab-aekn) injection as interchangeable with reference biologic ...

Stelara is a biologic medicine used to treat moderate to severe Crohn’s disease and ulcerative colitis. Crohn’s disease and ulcerative colitis are inflammatory bowel diseases that cause inflammation ...

Celltrion has obtained the Food and Drug Administration’s clearance for a new presentation of Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), in a 45mg/0.5ml solution in a ...

Credit: Fresenius Kabi. The FDA originally approved Otulfi as a biosimilar in October 2024 based on clinical data that demonstrated the product was highly similar to Stelara. Patients may now switch ...

Please provide your email address to receive an email when new articles are posted on . The FDA approved Steqeyma as the seventh Stelara biosimilar with an expected launch date of February 2025.

The approval was based on a totality of evidence, including data from a phase 3 study (ClinicalTrials.gov Identifier: NCT04967508) that compared the efficacy and safety of Pyzchiva to the reference ...

Samsung Bioepis Co. Ltd. has announced the marketing approval of Ustekinumab BS Subcutaneous Injection 45mg Syringes 'NIPRO', ...

Please provide your email address to receive an email when new articles are posted on . Four biosimilars for Stelara have launched in the United States this year following legal settlements with the ...