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

∇ This medicine is subject to additional monitoring. This will allow quick identification of new safety information.

LONDON, Dec. 2, 2025 /PRNewswire/ -- Accord Healthcare today announced the launch of Osvyrti (denosumab), a biosimilar to Prolia® (Amgen), and Jubereq (denosumab), a biosimilar to Xgeva® (Amgen), following the scheduled expiry of the reference medicine's patent on 27 November 2025.

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:

• The treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures.
• The treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.
• The treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

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

• Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.
• Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

"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

• Comparable increases in lumbar spine BMD at 12 months (6.25% vs. 6.36%).
• Equivalent pharmacokinetic, pharmacodynamic, safety, and immunogenicity profiles.
• Low anti-drug antibody incidence (≤1.6%) in both treatment groups, with no neutralising antibodies observed.
• No impact on efficacy or safety following treatment switch from the reference medicine to Osvyrti.
• These results support Osvyrti as a biosimilar and clinically interchangeable alternative to reference denosumab

JUBEREQ

• Proven bioequivalence to the reference denosumab, with no clinically meaningful differences in efficacy, safety, pharmacokinetics profile or immunogenicity
• Compared to their HRQOL status before experiencing their first SRE, patients with metastatic prostate cancer showed marked scores across quality-of-life domains following an SRE (Skeletal-Related-Events)
• Superior, sustained prevention of skeletal related events for >2 years, delaying time to first event vs. zoledronic acid
• No dose adjustments required in patients with renal impairment

Notes to editors:

• Osvyrti (denosumab) is a biosimilar to Prolia® (Amgen).
• The Phase 3 study (INTP23.1) was conducted in accordance with EMA and FDA biosimilar development guidelines.
• Prolia® is a registered trademark of Amgen Inc.
• This information is intended for healthcare and trade media and is not intended for use with patients or the general public.

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:

1. OSVYRTI^® (denosumab-desu) Prescribing Information. Accord BioPharma.
2. JUBEREQ^® (denosumab-desu) Prescribing Information. Accord BioPharma.
3. Amgen Reports Fourth Quarter and Full Year 2024 Financial Results.
   https://www.amgen.com/newsroom/press-releases/2025/02/amgen-reports-fourth-quarter-and-full-year-2024-financial-results
4. Accord BioPharma. Data on file.

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