New Era in Bone Health: Biosimilar Launch Promises Wider Access and Lower Costs

LONDON, UK – December 02, 2025 – A significant shift is underway in the treatment of debilitating bone conditions across Europe. Accord Healthcare today announced the launch of two new medicines, Osvyrti and Jubereq, set to challenge the high cost of treating osteoporosis and cancer-related bone complications. The move promises to expand access for millions of patients and deliver substantial savings to financially strained healthcare systems.

The new drugs are biosimilars of denosumab, a widely used biologic medicine previously sold exclusively under the brand names Prolia® and Xgeva® by Amgen. Following the recent expiry of key patents, Accord’s launch introduces direct competition, a development that health economists and patient advocates have long awaited. Osvyrti is approved for treating osteoporosis in postmenopausal women and men at high risk of fractures, as well as bone loss from certain cancer treatments. Jubereq is aimed at preventing serious skeletal events in patients with advanced cancers that have spread to the bone.

"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 launch is a key part of Accord's strategy to bring 20 biosimilars to market by 2030, signaling a deep commitment to reshaping the pharmaceutical landscape.

Addressing a Silent Epidemic

The impact of this development cannot be overstated, particularly for Europe's aging population. Osteoporosis, often called a “silent epidemic,” affects more than 200 million people worldwide. The condition weakens bones, making them susceptible to fractures that can lead to chronic pain, disability, and a loss of independence. Globally, one in three women and one in five men over the age of 50 will experience a fracture due to osteoporosis.

For cancer patients, the stakes are equally high. When cancer metastasizes to the bone, it can cause skeletal-related events (SREs)—such as pathological fractures or spinal cord compression—that severely diminish quality of life. Denosumab has been a cornerstone of therapy for both conditions, but its cost has limited access for many.

The approval of Osvyrti and Jubereq by the European Medicines Agency (EMA) was based on extensive clinical trials demonstrating that they are “highly similar” to their reference products. The studies confirmed equivalent profiles in terms of efficacy, safety, and how the body processes the drug. For patients and clinicians, this provides assurance that they can switch to the biosimilar with confidence, receiving the same therapeutic benefit at a potentially much lower price point.

The Biosimilar Wave Reshaping European Healthcare

Accord's launch is not an isolated event but part of a powerful wave of biosimilar competition transforming European healthcare. Since the EMA created the world’s first regulatory pathway for biosimilars in 2006, the market has matured into a formidable force for sustainability. According to recent industry analyses, cumulative savings from biosimilar competition in Europe surpassed an estimated €56 billion as of mid-2024.

This “biosimilar dividend” allows national health systems to reallocate funds to other areas of need, from hiring more nurses to investing in innovative new treatments. The European biosimilar market, valued at over $12 billion in 2024, is projected to nearly triple in size by 2031, fueled by a pipeline of blockbuster drugs losing patent protection.

Between now and 2032, an estimated 110 biologic medicines are expected to lose exclusivity in Europe, representing a massive opportunity to drive down costs further. The introduction of denosumab biosimilars is a prime example of this trend in action, targeting a market where the originator products generated over $6.5 billion in global revenue last year.

A Crowded Field Promises a Competitive Future

Accord Healthcare is entering a dynamic and increasingly crowded field. The patent expiry of Prolia and Xgeva has triggered a race among pharmaceutical companies to capture a share of the lucrative denosumab market. Major players like Sandoz, Teva Pharmaceutical Industries, and a partnership between Organon and Henlius have all secured EMA approval for their own denosumab biosimilars, with launches happening across Europe.

This intense competition is precisely what healthcare systems hope for. As multiple biosimilars enter the market, price pressure on both the originator drug and the biosimilars themselves is expected to increase, maximizing savings. While originator company Amgen has engaged in legal battles to defend its market share, the wave of biosimilar entries is now an established reality.

For companies like Accord, success depends not only on securing regulatory approval but also on navigating complex national tender systems and building trust with physicians and hospital administrators. Their stated goal of a broad biosimilar portfolio suggests a long-term strategy focused on becoming a key partner for healthcare systems seeking to manage pharmaceutical budgets responsibly.

From Approval to Adoption: The Final Hurdle

While the launch of cost-effective biosimilars is a critical step, the full impact on patient care and health budgets hinges on their adoption by clinicians. Historically, the uptake of biosimilars has faced hurdles, including a lack of physician awareness and lingering skepticism about their equivalence to originator products.

However, the landscape is shifting. Years of positive real-world data and concerted educational efforts are building confidence. A pivotal moment came in 2022 when the EMA, along with the Heads of Medicines Agencies (HMA), issued a statement confirming that any biosimilar approved in the EU can be considered interchangeable with its reference product. This declaration provides a strong scientific and regulatory foundation for physicians to confidently prescribe and switch patients to biosimilars.

Still, effective communication with both doctors and patients remains essential to overcome any remaining hesitancy. Patient advocacy groups have emphasized the importance of framing biosimilars not as a lesser option, but as a vital tool for ensuring equitable and sustainable access to high-quality biologic medicines. As these new denosumab biosimilars become available in clinics and hospitals, their success will be a testament to the collaboration between regulators, manufacturers, and healthcare providers dedicated to making progress for people.