New Biosimilars Arrive to Strengthen Bone Health and Healthcare Budgets

LONDON, UK – December 02, 2025 – For millions of people, the fear of a fall is more than a momentary concern; it's a life-altering threat. Osteoporosis, a silent condition that weakens bones from within, affects over 200 million individuals globally. For cancer patients, the disease can spread to the bones, causing excruciating pain and catastrophic fractures. In both cases, the human cost is immense, measured in lost independence, chronic suffering, and a heavy burden on families and healthcare providers. But a significant shift is underway, promising to make crucial, life-changing treatments more accessible than ever before.

This week, Accord Healthcare announced the European launch of Osvyrti and Jubereq, two new medicines poised to have a profound impact on bone health. These are not new chemical discoveries but a different kind of innovation: biosimilars. They are highly similar, rigorously tested versions of existing, effective biologic drugs whose patents have just expired. This development marks a pivotal moment, signaling a new era where competition can drive down costs, unlocking access to vital therapies for countless patients across the continent.

The Silent Epidemic and Its Human Cost

To understand the significance of this launch, one must first grasp the scale of the challenge. Osteoporosis leads to a fracture every three seconds worldwide. According to the International Osteoporosis Foundation, approximately one in three women and one in five men over the age of 50 will experience an osteoporotic fracture. These are not minor injuries; a hip fracture can be a gateway to decreased mobility, a need for long-term care, and a stark increase in mortality rates. The condition quietly hollows out the very framework of the body, often going undiagnosed until the first, devastating break occurs.

Beyond osteoporosis, patients battling advanced cancers face a parallel struggle. When malignancies spread to the skeleton, they can trigger what doctors call skeletal-related events (SREs)—pathological fractures, the need for radiation to the bone, or even compression of the spinal cord. These events dramatically degrade a patient's quality of life, layering intense physical pain on top of an already difficult fight. For these individuals, treatments that can prevent or delay SREs are not just about managing a symptom; they are about preserving dignity and maintaining a semblance of normalcy.

A New Era of Access and Affordability

The original drugs, Amgen’s Prolia® and Xgeva®, have been cornerstones of treatment for these conditions for years, generating billions in revenue. Their effectiveness is well-established, but their high cost has often placed them just out of reach for health systems with constrained budgets and for patients in certain regions. With the recent expiry of their European patents, the door has opened for biosimilar competition.

Accord Healthcare’s Osvyrti is a biosimilar to Prolia®, aimed at treating osteoporosis and bone loss from certain cancer therapies. Its counterpart, Jubereq, is a biosimilar to Xgeva®, developed to prevent SREs in patients with advanced cancers involving bone. Their arrival, alongside biosimilars from other companies, is set to create a more competitive marketplace, which historically leads to significant price reductions.

This isn't just a business development; it's a public health breakthrough. The potential savings—in a European market for these drugs valued at approximately €1 billion—can be redirected by national health services to fund more diagnostic screenings, hire more specialist nurses, or invest in other critical areas of patient care.

"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," said Paul Tredwell, Global CEO of Accord Healthcare, in the company’s announcement. This statement underscores the core mission of biosimilar development: democratizing access to modern medicine. It reflects a strategic push by the company, which aims to have 20 biosimilars on the market by 2030, targeting areas of high clinical need.

The Science of Trust: Ensuring Quality and Safety

For patients and their doctors, the word "biosimilar" can raise questions. Is it just as good? Is it safe? The European Medicines Agency (EMA), one of the world's most respected regulatory bodies, has a clear and rigorous answer. Before a biosimilar like Osvyrti or Jubereq can be approved, its manufacturer must prove through extensive testing that it is "highly similar" to the original drug. This means demonstrating there are no clinically meaningful differences in terms of quality, safety, and efficacy.

The approval of Accord’s denosumab biosimilars was based on a comprehensive data package, including multi-phase clinical trials. For example, a Phase III study directly compared Osvyrti to Prolia® in postmenopausal women with osteoporosis. The results showed comparable increases in bone mineral density, equivalent safety profiles, and a similar immune response. Crucially, the study also found no negative impact on efficacy or safety when patients were switched from the original drug to the biosimilar, a key piece of evidence for building clinical confidence.

This exhaustive scientific validation is the bedrock of trust in biosimilars. It assures the medical community that they are not choosing a lesser option, but rather a clinically equivalent alternative that offers the powerful benefit of improved affordability. This assurance is vital for encouraging widespread adoption and realizing the full potential of these medicines to help more people.

The Ripple Effect on Lives and Health Systems

The true impact of this innovation will be felt far beyond pharmaceutical boardrooms and regulatory agencies. It will be measured in the lives of individuals. For a retired teacher living on a fixed income, an affordable osteoporosis treatment could mean the freedom to continue gardening, playing with her grandchildren, and living independently in her own home. For a father undergoing treatment for prostate cancer, a therapy that prevents bone complications can mean more quality time with his family, with less pain and fewer hospital visits.

By expanding the pool of patients who can access these treatments, Osvyrti and Jubereq contribute to a more resilient and equitable healthcare ecosystem. The financial relief they provide allows for a virtuous cycle, where savings from one area can strengthen another. This shift is part of a larger movement in medicine, where innovation is not only about discovering the next scientific marvel but also about finding sustainable ways to deliver the benefits of existing marvels to everyone who needs them.

The launch of these denosumab biosimilars is more than just a new product release; it represents a tangible step forward in the ongoing effort to balance innovation with accessibility. As populations age and the prevalence of chronic diseases like osteoporosis continues to rise, the role of high-quality, cost-effective biosimilars will only become more critical in building a healthier future for all.