At the same time, 90% of U.S. prescriptions are either generics or biosimilars saving the U.S. healthcare system $445 billion in 2023 alone. Despite these achievements, there are important reforms ...

Novartis' soon-to-be-divested Sandoz unit has positive clinical trial data in hand for a biosimilar of Amgen's blockbuster osteoporosis therapy Prolia (denosumab), clearing the way for regulatory ...

According to a settlement between Amgen and Celltrion, the biosimilars can be launched as early as June 1. The FDA has approved two new biosimilars of denosumab for all indications of the ...

Ospomyv and Xbryk, biosimilars to Prolia and Xgeva, received FDA approval for osteoporosis and bone loss treatment. Clinical studies confirmed equivalent efficacy, safety, and pharmacokinetics ...

A biosimilar medicine is a medicine that has a similar, but not identical, active ingredient to the reference (first) medicine. Because of this, a biosimilar should be thought of as being a medicine ...

1. The Department of Health has confirmed that a remit referred to NICE enables NICE to decide to apply the same remit, and resulting guidance, to relevant licensed biosimilar products which ...