Accord Healthcare Announces Launch of Denosumab∇ - Second Biosimilar in Bone Health

Both medicines were approved by the European Medicines Agency (EMA) in September of this year following trials versus their reference product showing they are highly similar to the Prolia® (Amgen). Both medicines were approved by the European Medicines Agency (EMA) in September of this year following trials versus their reference product showing they are highly similar to the Prolia® (Amgen). Denosumab marks the company's second biosimilar launch within its bone health portfolio, further...

LONDON, 02/12/2025 (informazione.news - comunicati stampa - salute e benessere)

Both medicines were approved by the European Medicines Agency (EMA) in September of this year following trials versus their reference product showing they are highly similar to the Prolia® (Amgen).

Denosumab marks the company's second biosimilar launch within its bone health portfolio, further expanding Accord's commitment to improving patient access to high-quality, cost-effective medicines in areas of high clinical need.

Supporting clinicians and healthcare systems in bone health

Osvyrti (denosumab) available as a 60 mg pre-filled syringe is indicated for¹:

Jubereq (denosumab) available as a 120 mg vial is indicated for²:

"Both OSVYRTI and JUBEREQ have been approved for a wide variety of bone-related indications, including osteoporosis and bone loss from the treatment of certain kinds of cancer," said Paul Tredwell, Global CEO of Accord Healthcare. "These biosimilars have the potential to provide a large number of patients with treatment alternatives that lessen cost as a barrier to accessing proven therapies. At Accord, we are passionate about leading biosimilar adoption, and OSVYRTI and JUBEREQ represent important progress in expanding access, supporting our strategic drive to have 20 biosimilars on the market by 2030."

Addressing the burden of osteoporosis

Osteoporosis is a chronic condition characterised by reduced bone mass and structural deterioration, leading to an increased risk of fractures.

It affects more than 200 million people globally, with around one in three women and one in five men over 50 years experiencing osteoporotic fractures in their lifetime. As populations age, the prevalence and economic impact of osteoporosis are expected to continue rising, placing additional pressure on healthcare systems.

OSVYRTI

JUBEREQ

Notes to editors:

About OSVYRTI and JUBEREQ
The approval of OSVYRTI and JUBEREQ was based on results from two trials: a Phase I trial and a Phase III trial that met their primary endpoints. The Phase I trial was a randomized, double-blind, three-arm pharmacokinetic (PK) study comparing JUBEREQ to Xgeva in healthy adult males. The study demonstrated that PK parameters were found to be comparable between the two products.⁴ The Phase III study was a randomized, double-blind, active-controlled, parallel arm, multicenter study comparing PK/PD, efficacy and safety of OSVYRTI to Prolia in postmenopausal women with osteoporosis. The clinical study results demonstrated that OSVYRTI and its reference product, Prolia, are highly similar, and have no clinically meaningful differences in terms of PK, PD, safety and efficacy.^2,4

About Accord Healthcare
Accord Healthcare is one of the fastest-growing generic and biosimilar pharmaceutical companies in the UK and Europe. Through its focus on quality, accessibility, and sustainability, Accord works with healthcare professionals and the NHS to improve patient outcomes and deliver value across therapeutic areas including oncology, bone health, and autoimmune disease.

References:

Logo - https://mma.prnewswire.com/media/2799417/Accord_Plasma_Logo.jpg

View original content:https://www.prnewswire.co.uk/news-releases/accord-healthcare-announces-launch-of-denosumab---second-biosimilar-in-bone-health-302629600.html