biosimilar - Diplomacy & Trade https://dteurope.com Monthly in print | Daily on the web Mon, 29 Sep 2025 10:27:26 +0000 en-US hourly 1 https://wordpress.org/?v=6.9.4 https://dteurope.com/wp-content/uploads/cropped-dt_favicon-32x32.png biosimilar - Diplomacy & Trade https://dteurope.com 32 32 First FDA-Approved Biosimilar for Gedeon Richter https://dteurope.com/business/first-fda-approved-biosimilars-for-gedeon-richter/ Mon, 29 Sep 2025 09:08:00 +0000 https://dteurope.com/?p=75428 Gedeon Richter Plc. and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) announcee this Monday that the U.S. Food and Drug Administration (FDA) has granted approval for the Biologics License Applications (BLA) of their biosimilar denosumab products, EnobyTM (denosumab-qbde) and XtrenboTM (denosumabqbde), referencing Prolia® and Xgeva®, respectively. Denosumab is […]

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]]> Two Richter Products Recommended for Marketing https://dteurope.com/business/two-richter-products-recommended-for-marketing/ Fri, 25 Apr 2025 16:10:00 +0000 https://dteurope.com/?p=73513 Budapest-based pharmaceutical company Gedeon Richter Plc. has received positive opinion from CHMP for marketing authorization for Junod and Yaxwer, its biosimilar denosumab products for bone disease and osteoporosis. Budapest-based pharmaceutical company Gedeon Richter Plc. has announced on the website of the Budapest Stock Exchange that it received a positive opinion from the Committee for Medicinal […]

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]]> European Acceptance for Richter's Drug, Tocilizumab https://dteurope.com/business/european-acceptance-for-richters-drug-tocilizumab/ Thu, 27 Mar 2025 17:25:00 +0000 https://dteurope.com/?p=73051 The Hungarian pharmaceutical company Gedeon Richter Plc. has announced on the website of the Budapest Stock Exchange that the European Medicines Agency (EMA) has accepted Richter’s marketing authorization application (MAA) for its proposed biosimilar to RoActemra tocilizumab. Tocilizumab, the first biologic to inhibit IL-6 signaling, is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic […]

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