Novartis: first patient picked for osteoporosis trial

(CercleFinance.com) - A first patient has been enrolled in Sandoz's Phase I/III clinical study for a proposed biosimilar in patients with osteoporosis.


The study aims to confirm that the biosimilar matches the reference medicine, Amgen's denosumab, in terms of pharmacokinetics, efficacy, safety, and immunogenicity in patients with postmenopausal osteoporosis.

In the trial, approximately 520 postmenopausal patients with osteoporosis will be randomized to receive either biosimilar denosumab or the reference medicine for 52 weeks.

Approximately 200 million people worldwide suffer from osteoporosis.

Sandoz is Novartis's generics business.

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