Accord Healthcare has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its denosumab biosimilars, marking a significant advancement in expanding access to critical treatments for bone disorders and cancer.
The CHMP recommendation covers two branded formulations: Osvyrti® (60mg pre-filled syringe) for osteoporosis and bone health indications, and Jubereq® (120mg vial) for oncology applications. This regulatory milestone paves the way for potential European Commission approval in the coming months.
Joe Dunford, Accord's Vice President of Specialty Brands, emphasized the importance of this development: "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."
Dunford further noted that "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."
Strategic Portfolio Expansion
The addition of denosumab biosimilars represents a calculated expansion of Accord's therapeutic offerings. Denosumab is a monoclonal antibody that inhibits RANKL (receptor activator of nuclear factor kappa-B ligand), a key mediator in bone resorption. At the 60mg dosage (Osvyrti®), it is primarily used to treat postmenopausal osteoporosis and increase bone mass in patients at high fracture risk.
The 120mg formulation (Jubereq®) is indicated for preventing skeletal-related events in patients with bone metastases from solid tumors and for treating giant cell tumor of bone in adults and skeletally mature adolescents.
This approval strengthens Accord's position in both therapeutic areas, particularly in oncology where the company has established a substantial presence. According to company statements, Accord currently offers more than 54 oncology and oncology-related treatments across Europe, making it one of the region's largest suppliers of chemotherapy products.
Market Impact and Patient Access
Headquartered in the United Kingdom, Accord Healthcare has positioned itself as one of Europe's fastest-growing pharmaceutical companies. The firm has developed an extensive market footprint that ensures over 95% of European patients can access vital medicines.
The introduction of biosimilar versions of denosumab could significantly impact healthcare economics across Europe. Biosimilars typically enter the market at lower prices than their reference products, potentially reducing treatment costs while maintaining therapeutic efficacy. This aligns with Accord's stated mission of improving patient access to essential medications.
Future Growth Trajectory
Beyond the current approval, Accord has indicated a robust development pipeline with approximately 20 additional treatments scheduled for launch over the next five years. This forward-looking approach reflects the company's commitment to sustainable growth and continued innovation in key therapeutic areas.
"Our approach is agile and inventive, always seeking to improve our products and patients' access to them," noted company representatives. "We're driven to think differently and deliver more for the benefit of patients worldwide."
The positive CHMP opinion for denosumab represents not only a regulatory achievement but also reinforces Accord's strategic vision of expanding its specialty pharmaceutical business while addressing critical patient needs across Europe.
