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

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 ...

Taken alongside Prolia/Xgeva, the brands account for well over 40% of Amgen's current revenues. Other companies working on biosimilar versions of denosumab include Samsung Bioepis, Celltrion, and ...

The AVT03-GL-C01 study, which met its primary endpoints, demonstrated clinical similarity of AVT03 to Prolia in terms of efficacy, safety, immunogenicity, and pharmacokinetics (PK) in 532 ...

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.

The AVT03-GL-C01 study, which met its primary endpoints, demonstrated clinical similarity of AVT03 to Prolia in terms of efficacy, safety, immunogenicity, and pharmacokinetics (PK) in 532 ...