Hungary's Richter and Hikma receive FDA approval for denosumab biosimilars

ReutersSep 29, 2025 6:13 AM

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BUDAPEST, Sept 29 (Reuters) - Richter Gedeon Vegyeszeti Gyar Nyrt GDRB.BU says in a statement:

RICHTER AND HIKMA RECEIVE FDA APPROVAL FOR DENOSUMAB BIOSIMILARS ENOBYTM AND XTRENBO, REFERENCING PROLIA AND XGEVA, RESPECTIVELY
UNDER THE TERMS OF THE AGREEMENT RICHTER IS RESPONSIBLE FOR THE DEVELOPMENT AND MANUFACTURE OF THE PRODUCTS
HIKMA IS RESPONSIBLE FOR THE FDA REGISTRATION AND EXCLUSIVE COMMERCIALIZATION IN THE U.S.
DENOSUMAB IS INDICATED FOR TREATING OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN

Source text: [https://www.bse.hu/newkibdata/129324268/Denosumab_FDA_Approval_Sep2025_EN.pdf]

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