Dr Reddy’s Gets European Nod For Biosimilar To Treat Osteoporosis
Prolia is a prescription medicine used to treat osteoporosis in women who have been through menopause and in men who are at increased risk of fractures.
Dr Reddy’s Laboratories on Monday said the European Commission has granted marketing authorisation for its biosimilar to treat osteoporosis.
The company has received approval for AVT03, a biosimilar of Prolia (denosumab) and Xgeva (denosumab), the Hyderabad-based drug firm said in a statement.
Prolia is a prescription medicine used to treat osteoporosis in women who have been through menopause and in men who are at increased risk of fractures, bone loss linked to hormone ablation in men with prostate cancer at increased risk of fractures and bone loss associated with long-term treatment with systemic glucocorticoids.
Xgeva is also a prescription medicine used to prevent bone complications in adults with advanced cancer involving bone and for the treatment of adults and skeletally mature adolescents with giant cell tumours of bone.
The EC decision is valid in all EU member states as well as in the European Economic Area countries Iceland, Liechtenstein and Norway.
In May 2024, Dr Reddy’s and Alvotech entered into a license and supply agreement for the commercialisation of AVT03.
Under the agreement, Alvotech will develop and manufacture AVT03, while Dr Reddy’s is responsible for registration and commercialisation in applicable markets, including the US and Europe.
Dr Reddy’s shares on Monday ended 1.59% down at Rs 1,224.75 apiece on BSE.
