Henlius and Organon announced US FDA has accepted the Biologics License Application (BLA) for HLX14, biosimilar candidate of ...

two-arm pilot study with the primary objective to compare the PK parameters of HLX14 and EU-sourced PROLIA after subcutaneous injection to provide further basis for the study design of part 2.

Regulators are also reviewing Teva’s application for its Prolia biosimilar candidate. The FDA’s decisions are expected mid-year 2025. The FDA has accepted the biologic license application (BLA) for ...

Consumers need to be informed and aware of the side-effects associated with using the osteoporosis drug Prolia, says Consumers Health Forum of ...

Organon (NYSE:OGN) and partner Shanghai Henlius Biotech said the FDA has accepted the Biologics License Application for HLX14, a biosimilar of Amgen’s (AMGN) Prolia/Xgeva, also known as denosumab.

Doctors acknowledge Prolia can have serious side effects ... making up more than 70 per cent of market share It's administered by injection every six months, and can't be late or skipped It ...