Novartis: reports positive results for denosumab trial
(CercleFinance.com) - Sandoz announces further progress in its biosimilars portfolio with the release of positive results from the integrated Phase I/III clinical trial for denosumab.
The ROSALIA study met the primary endpoints, confirming that the proposed biosimilar denosumab matches the reference product in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in postmenopausal women with osteoporosis.
The trial's positive results follow the acceptance for filing of two other proposed Sandoz biosimilars - adalimumab HCF and natalizumab - by the EMA and FDA
Osteoporosis is responsible for 8.9 million bone fractures per year, including debilitating hip fractures - a number that is expected to increase significantly over the next two decades.
Copyright (c) 2022 CercleFinance.com. All rights reserved.
The ROSALIA study met the primary endpoints, confirming that the proposed biosimilar denosumab matches the reference product in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in postmenopausal women with osteoporosis.
The trial's positive results follow the acceptance for filing of two other proposed Sandoz biosimilars - adalimumab HCF and natalizumab - by the EMA and FDA
Osteoporosis is responsible for 8.9 million bone fractures per year, including debilitating hip fractures - a number that is expected to increase significantly over the next two decades.
Copyright (c) 2022 CercleFinance.com. All rights reserved.