#London #UK #Accord Healthcare #OSVYRTI #Jubereq

Accord Healthcare Expands Bone Health Portfolio with New Biosimilars

Accord Healthcare has officially launched two new biosimilars—Osvyrti (denosumab) and Jubereq (denosumab)—signifying a noteworthy expansion in their offerings for patients dealing with bone health issues. These products serve as biosimilar alternatives to Prolia® and Xgeva®, both developed by Amgen, following the expiration of patent protection for these reference drugs on November 27, 2025.

Significance of the Launch

The approvals for Osvyrti and Jubereq were granted by the European Medicines Agency (EMA) after successful trials demonstrated their equivalence to their respective reference products. This launch marks Accord's second foray into the biosimilar market within the bone health segment, underscoring the company's commitment to enhancing patient access to essential healthcare solutions. Paul Tredwell, Global CEO of Accord Healthcare, stated, “Both Osvyrti and Jubereq have been approved for a wide range of bone-related conditions, providing patients with economical alternatives that can remove financial barriers to accessing critical treatments.”

Treatment Applications

Osvyrti (Denosumab)

Osvyrti is available in a 60 mg pre-filled syringe form and is targeted at:

• - Treating osteoporosis in postmenopausal women and men who are at increased risk of fractures.
• - Managing bone loss due to hormone ablation treatments in men with prostate cancer who face fracture risks.
• - Mitigating bone loss linked to prolonged systemic glucocorticoid therapy in adults.

Jubereq (Denosumab)

On the other hand, Jubereq is provided in a 120 mg vial and is indicated for:

• - Preventing skeletal-related events in adults with advanced malignancies that involve the bone.
• - Treating adults and skeletally mature adolescents with unresectable giant cell tumors of the bone or when surgical resection is anticipated to lead to significant morbidity.

Tackling Osteoporosis

Osteoporosis represents a severe global health challenge, affecting over 200 million people worldwide. With approximately one in three women and one in five men over the age of 50 facing potential osteoporotic fractures in their lifetimes, the need for effective treatment options is paramount. As populations age, the incidence and economic burden linked to osteoporosis are expected to escalate, exerting additional strain on healthcare systems. Accord Healthcare aims to tackle this burden head-on by providing cost-effective biosimilars that can improve patient outcomes.

Clinical Study Highlights

The clinical studies for both Osvyrti and Jubereq showcased impressive results:

• - Osvyrti exhibited comparable increases in lumbar spine BMD after 12 months, showing a 6.25% increase in one group versus a 6.36% in the reference group, with a high safety profile and minimal incidence of anti-drug antibodies.
• - Jubereq demonstrated proven bioequivalence to the reference product, ensuring that there are no clinically meaningful differences in their efficacy, safety, and pharmacokinetics. It also proved superior in preventing skeletal-related events over a sustained period, further establishing its value in treatment plans.

A Step Towards Accessibility

Accord Healthcare's drive to launch Osvyrti and Jubereq reflects its long-term strategic goal of introducing twenty biosimilars into the market by 2030. The company firmly believes that by leading the charge in biosimilar adoption, it can facilitate wider access to necessary therapies for patients across the globe, thus improving overall health outcomes.

In conclusion, the launch of Osvyrti and Jubereq not only expands Accord Healthcare’s product offering but also enhances its mission to support clinicians and healthcare systems in addressing crucial bone health issues, which in turn, represents a significant stride towards improving patient care.

About Accord Healthcare

Accord Healthcare is emerging as one of the fastest-growing pharmaceutical companies in the UK and Europe, focusing on generic and biosimilar solutions. Committed to quality, accessibility, and sustainability, Accord collaborates closely with healthcare professionals and organizations to enhance patient outcomes in various therapeutic areas, including oncology and autoimmune diseases.