Accord Healthcare Receives Positive CHMP Opinion for Denosumab, Osvyrti®, and Jubereq®

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• Denosumab marks Accord's sixth biosimilar approval in Europe.
• The CHMP has issued a positive opinion for Denosumab, to be marketed as Osvyrti^® and Jubereq^®.
• Osvyrti^® is Accord's second osteoporosis biosimilar, following Sondelbay^®.
• The CHMP's endorsement paves the way for market authorization, with Accord set to launch Denosumab following patent expiry in November 2025 of the brand originator Prolia and Xgeva (Amgen denosumab brands).

LONDON, April 2, 2025 /PRNewswire/ -- Accord Healthcare Limited (Accord) is pleased to announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Denosumab, including its branded formulations Osvyrti^® and Jubereq^®, across its autoimmune and oncology therapy areas.

Product Indications

Osvyrti^® – Bone / Osteoporosis (60mg Pre-Filled Syringe)

• Indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. Denosumab has been shown to significantly reduce the risk of vertebral, non-vertebral, and hip fractures.
• Indicated for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, reducing the likelihood of vertebral fractures.
• Indicated for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

Jubereq^® – Oncology (120mg Vial)

• Indicated for the prevention of skeletal-related events (including pathological fractures, radiation to bone, spinal cord compression, or bone surgery) in adults with advanced malignancies involving bone.
• Indicated for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection would likely result in severe morbidity.

Joe Dunford, Accord's Vice President of Specialty Brands, commented:

"At Accord, we are dedicated to transforming patients' lives, and the recent CHMP approval of these vital medicines is a significant milestone. Osvyrti^® enhances our bone health portfolio, joining Sondelbay^®, our previously launched teriparatide biosimilar. Additionally, Jubereq^® expands our oncology product portfolio and underscores our commitment to advancing our specialty business and driving innovation in oncology - a field in which we have a rich heritage.

As a market leader in oncology, we offer over 54 oncology and oncology-related treatments, including small molecule generics, biosimilars, and new chemical entities. This makes us one of the largest suppliers of chemotherapy products in Europe."

About Accord Healthcare

Headquartered in the United Kingdom (UK), Accord Healthcare, Ltd. is one of the fastest growing pharmaceutical companies in Europe.

Accord has one of the largest market footprints among European companies in its category ensuring that over 95% of European patients get access to vital medicines. Accord has over 54 oncology and oncology-related treatments making it one of the largest suppliers of chemotherapy products in Europe with an additional 20 treatments which are currently in development and scheduled for launch over the next 5 years.

Our approach is agile and inventive, always seeking to improve our products and patients' access to them. We're driven to think differently and deliver more for the benefit of patients worldwide.

www.accord-healthcare.com

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