International Biosimilars Updates
On April 21, 2026, Biocon announced that Health Canada granted a Notice of Compliance (NOC) for BOSAYATM (denosumab) and VEVZUOTM (denosumab), biosimilars of Amgen’s Prolia® (denosumab) and Xgeva® (denosumab).
Denosumab is a human monoclonal antibody that targets and binds to Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL). In Canada, BOSAYATM is indicated for the treatment (i) of postmenopausal women with osteoporosis at high risk for fracture; (ii) to increase bone mass in men with osteoporosis at high risk for fracture; (iii) to increase bone mass in men with nonmetastatic prostate cancer receiving androgen deprivation therapy (ADT), who are at high risk for fracture; (iv) to increase bone mass in women with nonmetastatic breast cancer receiving adjuvant aromatase inhibitor therapy; and (v) to increase bone mass in women and men at high risk for fracture due to sustained systemic glucocorticoid therapy and fracture who are starting or have recently started long term glucocorticoid therapy. In Canada, VEVZUOTM is indicated for (i) reducing the risk of developing skeletal-related events in patients with multiple myeloma and in patients with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer, and other solid tumors; (ii) adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity; and (iii) treatment of hypercalcemia of malignancy that is refractory to intravenous bisphosphonate.
This approval comes a few weeks after Biocon launched their denosumab biosimilars, marketed under the names BOSAYATM (denosumab-kyqq) and AUKELSOTM (denosumab-kyqq), in the United States.
Additionally, on April 29, 2026, Shanghai Henlius and Organon announced that the European Commission (EC) granted marketing authorization for POHERDY® (pertuzumab), a biosimilar to PERJETA® (pertuzumab), for the same indications as the reference product. As is the case in the United States, POHERDY® is the first and only pertuzumab biosimilar to receive regulatory approval in Europe.
Pertuzumab is a HER2 inhibitor that is administered via an intravenous infusion with other agents and chemotherapies. In Europe, POHERDY® is indicated in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. POHERDY® is also indicated for use in combination with trastuzumab and chemotherapy as (i) neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer at high risk of recurrence; and (ii) adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.
In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to several biosimilars, including POHERDY®. The agreement covers exclusive global commercialization rights except for China.
The post International Biosimilars Updates appeared first on Big Molecule Watch.