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

Gedeon Richter

29/09/2025 07:05

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]

Further company coverage: GDRB.BU

 (Reporting by Anita Komuves)

 ((KOMUVES.Anita@thomsonreuters.com;))