Category: Europe

October 21, 2024 Off

Lindis Biotech gets positive CHMP Opinion for Korjuny in the EU

By Dino Mustafić

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of Lindis Biotech’s trifunctional Korjuny (catumaxomab), anti-CD3 x anti-EpCAM antibody (trAb) for the intraperitoneal treatment of malignant ascites (MA) in adults with EpCAM-positive carcinomas who are not eligible for further systemic anticancer therapy.

September 30, 2024 Off

Formycon and Fresenius Kabi receive FDA approval for FYB202/ OtulfiTM

By Dino Mustafić

Formycon AG and its commercialization partner Fresenius Kabi jointly said Monday that the U.S. Food and Drug Administration (FDA) has approved FYB202/OtulfiTM1 (ustekinumab-aauz), a biosimilar to Stelara, for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis, the third Formycon biosimilar successfully approved by the FDA.