Teva Enters Europe's Crowded $1.2B Bone Drug Market

TEL AVIV, Israel – November 25, 2025 – Teva Pharmaceutical Industries has secured European Commission marketing authorizations for two new biosimilar drugs, PONLIMSI® and DEGEVMA®, positioning the company to compete for a major share of Europe's lucrative bone health market. The approvals allow Teva to launch its versions of denosumab, a widely used monoclonal antibody for treating osteoporosis and preventing serious bone complications in cancer patients.

PONLIMSI® is a biosimilar to Amgen’s blockbuster drug Prolia®, while DEGEVMA® references Amgen's Xgeva®. The move intensifies the competitive pressure on Amgen and marks a significant milestone in Teva's corporate strategy, promising to increase patient access and drive down costs for European healthcare systems.

A Billion-Dollar Market Opens to Competition

The approvals grant Teva access to a market with enormous clinical and financial stakes. The active ingredient, denosumab, is a cornerstone of modern therapy for bone density loss. Prolia is primarily used to treat osteoporosis in postmenopausal women and men at high risk of fractures, while Xgeva is indicated for preventing skeletal-related events like fractures and bone pain in patients with advanced cancers that have metastasized to the bone.

Together, Prolia and Xgeva represent Amgen's top-selling franchise, generating approximately $6.6 billion in global revenue in 2024. The European market alone accounts for an estimated $1.2 billion annually, making it a high-value target for biosimilar developers. The introduction of cost-effective alternatives is poised to disrupt this long-standing revenue stream for the originator.

The mechanism of denosumab involves targeting RANKL, a protein essential for the formation and survival of osteoclasts - the cells that break down bone tissue. By inhibiting RANKL, the drug effectively slows bone resorption, strengthening bones and reducing the risk of debilitating fractures. Teva's biosimilars have demonstrated comparable quality, safety, and efficacy to the reference products through comprehensive clinical data.

Teva Joins a Fiercely Competitive Biosimilar Race

While a significant achievement for Teva, the company is not the first to the European finish line. It enters a dynamic and increasingly crowded field, as key patents protecting Prolia and Xgeva have been expiring across major European markets since 2022, with final protections in countries like France and Italy lapsing in 2025. This has opened the floodgates for a wave of biosimilar competition.

Sandoz, a division of Novartis, became the first company to receive European approval for its denosumab biosimilars back in May 2024. Other major players including Celltrion, Samsung Bioepis, and Alvotech (in partnership with STADA and Dr. Reddy's Laboratories) have also secured marketing authorizations in 2025. With applications from firms like Fresenius Kabi and Gedeon Richter under review, the market is set for intense competition.

This multi-player landscape signals a fundamental shift from a single-supplier market to a competitive environment. While this presents a challenge for each individual company vying for market share, it is expected to accelerate price erosion and maximize savings for national health payers.

A Key Victory for Teva's 'Pivot to Growth'

For Teva, these approvals are a critical validation of its 'Pivot to Growth' strategy, a corporate turnaround plan spearheaded by CEO Richard Francis since early 2023. The strategy aims to shift Teva from a defensive, generics-focused posture to a balanced biopharmaceutical company driven by growth from its innovative drugs and a robust biosimilar pipeline.

Biosimilars are a central pillar of this plan. Teva has publicly stated its goal to launch five new biosimilars by 2027 from its pipeline of 13 candidates. The successful European approval of PONLIMSI® and DEGEVMA® represents a major proof point that this strategy is delivering tangible results.

Steffen Nock, SVP Head of Biosimilars & Chief Science Officer at Teva, commented in a statement, “This approval represents an important step forward in increasing patient access to biosimilar therapies for serious bone conditions, underscoring our commitment to supporting better care for patients."

Adding to this, Michal Nitka, SVP Head Generics Europe & Global Head OTC, noted the broader impact. "Through product launches like these, we remain committed to providing additional treatment options for healthcare systems across Europe – especially in countries where access to biosimilars can still be improved."

Reshaping Patient Access and Challenging an Incumbent

The arrival of multiple denosumab biosimilars, now including Teva's, will have a profound ripple effect across the European healthcare ecosystem. The most immediate impact will be on Amgen, which has already acknowledged in financial filings that it anticipates "sales erosion driven by biosimilar competition" beginning in 2025. In response, Amgen has pursued an aggressive legal strategy, filing patent infringement lawsuits against nearly every competitor while also striking settlement deals to manage the timing of market entry.

Beyond the corporate battle, the primary beneficiaries will be patients and national health systems. Biosimilars typically launch with discounts ranging from 7% to 15% or more, creating immediate cost savings. For conditions as widespread as osteoporosis, these savings can be substantial. The economic burden of fragility fractures in Europe was estimated at €57 billion in 2019, highlighting the urgent need for more affordable, preventative treatments.

Health economics models project that denosumab biosimilars could save health systems hundreds of millions of dollars over the next five years. These savings can be reinvested to treat more patients, fund innovative new therapies, or improve diagnostic services. European countries with strong biosimilar uptake policies, like the UK's NHS which saved an estimated £800 million from biosimilars in 2019-2020, are well-positioned to capitalize on this new wave of competition. The era of single-source denosumab in Europe is officially over, heralding a new chapter of increased affordability and broader access for treating debilitating bone diseases.