Shanghai Henlius Biotech and Organon (OGN) announced that the U.S. FDA has accepted the Biologic License Application for HLX14, an investigational biosimilar of PROLIA/XGEVA. In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception to the agreement is China.
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