Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries, announced that the European Commission (EC) has granted marketing authorisations for its two denosumab biosimilar candidates.
These are PONLIMSI, a biosimilar to Prolia and DEGEVMA, a biosimilar to Xgeva.
The news follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) earlier this year.
PONLIMSI (denosumab) is indicated for osteoporosis in postmenopausal women and men at increased fracture risk and for bone loss linked to prostate cancer hormone therapy or long-term systemic glucocorticoid use.
The active substance, denosumab, is a human monoclonal IgG2 antibody that targets the protein RANKL, essential for the formation, function and survival of osteoclasts - the cells responsible for bone resorption.
By binding to RANKL with high affinity and specificity, denosumab prevents the interaction between RANKL and RANK, leading to a decrease in bone resorption in cortical and trabecular bone.
These approvals mark another significant milestone in Teva’s industry-leading biosimilars portfolio and its ongoing commitment to improving patient access to essential biologic therapies across Europe.
Teva plans to launch both products in key European markets in the coming months.
The approval represents an important step in advancing Teva’s Pivot to Growth strategy, reinforcing the company’s dedication to broadening access to biosimilar medicines for patients.
Steffen Nock, SVP Head of Biosimilars & Chief Science Officer, said: “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."
Michal Nitka, SVP Head Generics Europe & Global Head OTC, added: "Through product launches such as 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."