Fresenius Kabi

Formycon and Fresenius Kabi receive FDA approval for FYB202/OtulfiTM (ustekinumab-aauz), a biosimilar to Stelara®, for treating Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This marks Formycon's third successful FDA approval for a biosimilar, with Fresenius Kabi set to market OtulfiTM in the US no later than February 22, 2025, as per a patent settlement with Johnson & Johnson.

Formycon AG and Fresenius Kabi announce FDA approval of FYB202/Otulfi (ustekinumab-aauz), a biosimilar to Stelara, for treating Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. Fresenius Kabi can market Otulfi in the US by February 22, 2025, under a patent settlement. The approval marks Formycon's third FDA-approved biosimilar, with two in 2024 alone.

FYB202/Otulfi® received EC approval for subcutaneous and intravenous formulations, approved for Crohn’s disease, psoriasis, and psoriatic arthritis. Formycon and Fresenius Kabi announce EC marketing authorization for FYB202/Otulfi®, a biosimilar to Stelara®, valid in all EEA countries.

Tulisokibart, an anti-TL1A monoclonal antibody, outperformed placebo in inducing clinical remission at week 12 in moderate to severe ulcerative colitis, according to the ARTEMIS-UC trial. The study incorporated a predictive biomarker for response, showing significant clinical remission, endoscopic improvement, and clinical response in patients on tulisokibart compared to placebo. A phase 3 program is planned to confirm these results.

The global bulk-drug compounding market is projected to grow from USD 11,887.6 million in 2024 to USD 19,735.7 million by 2034, with a CAGR of 5.2%. Key drivers include rising demand for customized medications, chronic disease prevalence, and technological advancements. Major players include Fogron, B. Broun Melsungen AG, Nephron Pharmaceuticals Corporation, and others.

The global bulk-drug compounding market is projected to grow from USD 11,887.6 million in 2024 to USD 19,735.7 million by 2034, driven by demand for customized medications and chronic disease prevalence.