Marking a Milestone in Its Global Expansion Strategy

By: Russ Spencer

In a development widely recognized across the pharmaceutical industry as a major turning point for biosimilar access in Europe, Teva Pharmaceuticals International GmbH — a subsidiary of Teva Pharmaceutical Industries Ltd. — announced on Tuesday that the European Commission (EC) has granted marketing authorization for its two denosumab biosimilar candidates, PONLIMSI and DEGEVMA. As reported by Globe Newswire, these approvals represent a critical milestone in Teva’s expanding biosimilar portfolio and its long-term strategic initiative known as Pivot to Growth, which aims to accelerate the company’s position in global biopharmaceutical markets.

The EC decision follows earlier positive opinions from the Committee for Medicinal Products for Human Use (CHMP) issued this year. With regulatory endorsement now secured, Teva is preparing to launch both products across major European markets in the coming months, bringing new therapeutic options to patients in need while advancing the broader availability of cost-effective biologic alternatives.

According to Globe Newswire, the approvals signify far more than another expansion of Teva’s already formidable biosimilar pipeline. They underscore a historic shift toward broader accessibility of biologic medicines — a shift critically important in Europe, where biologics remain cost-prohibitive for many healthcare systems, despite their widespread clinical effectiveness.

In its announcement, Teva emphasized that PONLIMSI and DEGEVMA — both biosimilars to widely used treatments for serious bone-related disorders — will help meet the urgent clinical need for affordable therapies addressing osteoporosis, cancer-related bone complications, and rare bone tumors.

Steffen Nock, Teva’s Senior Vice President and Chief Science Officer for Biosimilars, articulated the broader meaning of the approval, telling Globe Newswire: “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.”

Similarly, Michal Nitka, Senior Vice President overseeing Generics Europe and Global OTC operations, stressed Teva’s goal of strengthening healthcare systems across the continent: “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.”

These statements echo Teva’s ongoing public commitments to affordability, patient access, and global health equity — objectives that have taken on new urgency as European healthcare budgets continue to face strain amid rising drug costs.

The first of the two approvals, PONLIMSI (denosumab), is poised to make a significant impact on the treatment of osteoporosis — a condition affecting millions of postmenopausal women and men throughout Europe.

As outlined by Globe Newswire, PONLIMSI is indicated for treatment of osteoporosis in postmenopausal women and men at increased fracture risk, bone loss associated with hormone ablation therapy in men with prostate cancer and bone loss resulting from long-term systemic glucocorticoid therapy in adults.

At the core of PONLIMSI is denosumab, a fully human monoclonal IgG2 antibody that targets RANKL, the essential protein driving the formation and survival of osteoclasts — the cells responsible for bone resorption. By inhibiting RANKL’s interaction with its receptor (RANK), the drug effectively slows bone loss across both cortical and trabecular bone.

Available as a 60 mg/1 mL pre-filled syringe, PONLIMSI parallels the formulation of Amgen’s Prolia®, a therapy authorized in the EU since 2010.

Teva’s biosimilar underwent extensive analytical, preclinical, and clinical review, as Globe Newswire documented, demonstrating comparable quality, therapeutic equivalence, and a consistent safety profile to the reference product.

For European patients — particularly aging populations in countries with soaring osteoporosis rates — the arrival of PONLIMSI is expected to increase treatment accessibility and reduce the cost barriers associated with long-term biologic therapy.

Teva’s second EC approval, DEGEVMA (denosumab), is an oncology-oriented biosimilar designed for the prevention of skeletal-related events in adults with advanced cancer involving bone.

Its approved indications, as reported by Globe Newswire, include prevention of bone complications in adults with metastatic cancer involving bone, and treatment of adults and skeletally mature adolescents with giant cell tumor of bone, a rare but serious neoplastic condition.

DEGEVMA employs the same RANKL-targeting mechanism as PONLIMSI but is formulated at a significantly higher dosage — 120 mg/1.7 mL in a vial — consistent with the reference treatment Xgeva®, authorized in the EU since 2011.

Like its counterpart, DEGEVMA demonstrated complete comparability to Xgeva® in rigorous testing, confirming that it meets all regulatory expectations for biosimilarity.

The expanded availability of denosumab biosimilars like DEGEVMA is expected to generate substantial cost savings for oncology treatment centers and national health systems, which have long grappled with the high costs of biologics in cancer-related bone disease management.

Teva’s dual approval represents a major victory for the company’s Pivot to Growth strategy — an ambitious plan to overhaul its global profile by investing heavily in specialty medicines, biosimilars, and complex generics.

Teva’s announcement to Globe Newswire framed these approvals as foundational to its long-term vision, signaling a strategic shift toward high-value biologics, a renewed focus on European market expansion and a strengthened commitment to specialty therapeutic areas such as oncology, bone health, and immunology.

With global demand for biosimilars projected to surge, Europe’s acceptance of Teva’s new offerings positions the company to compete vigorously with major biopharmaceutical players while delivering substantial savings to public healthcare systems.

As Globe Newswire has chronicled, Teva Pharmaceutical Industries Ltd. stands as one of the world’s most influential biopharmaceutical manufacturers, combining a century-long legacy in generics with a growing leadership role in biosimilars and innovative medicines.

For more than 120 years, Teva has been synonymous with accessible treatment solutions, pioneering research in neuroscience and immunology, global leadership in generic pharmaceuticals and a commitment to meeting unmet medical needs.

Today, Teva is capitalizing on its generics expertise to spearhead large-scale biosimilar development — a field requiring unparalleled precision, regulatory sophistication, and scientific rigor.

Through PONLIMSI and DEGEVMA, Teva is now positioned to deliver two critical therapies to millions of patients, reinforcing its corporate mission: “At Teva, We Are All In For Better Health.”

The European Commission’s approval of PONLIMSI and DEGEVMA — as reported by Globe Newswire — marks a pivotal advance in the European biosimilar landscape and a major step forward for Teva’s global ambitions.

By expanding access to high-quality denosumab biosimilars, Teva is strengthening patient access to essential therapies, supporting overburdened healthcare systems, accelerating competition in the biologics market, and demonstrating leadership at the intersection of innovation and affordability.

As both products launch across Europe in the coming months, stakeholders in healthcare, oncology, endocrinology, and pharmaceutical policy will be watching closely — not only to gauge market impact, but to understand how biosimilar expansion reshapes the future of cost-effective care on a continent increasingly dependent on innovative and sustainable medical solutions.

Teva’s announcement makes one fact unmistakably clear: the future of accessible biologic medicine in Europe has arrived — and Teva intends to lead it.