Biocon Biologics Gets FDA Approval for Osteoporosis Care

Biocon Biologics Ltd, a fully integrated global biosimilars company and a unit of Biocon Ltd, has obtained the US Food and Drug Administration (FDA) approval for their denosumab biosimilars, Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq). In addition, the US FDA has allowed both the therapies to have provisional interchangeability, a designation that facilitates the distribution of patients in the US, the area where the therapies can be used.

Not limited by indications, the US approval of Bosaya, denosimab biosimilar to Prolia, covers postmenopausal osteoporosis as a treatment, osteoporosis caused by glucocorticoid, and bone loss, which has been caused by therapy associated with breast and prostate cancer. Relating to the above, it is established that Aukelso, a biosimilar to Xgeva, is the prevention of the most severe complications related to the local tumor of multiple myeloma and is the spread of the tumor in the bones. Furthermore, the drug is assigned to treat giant cell tumor of bone and hypercalcemia of malignancy that is refractory.

Shreehas Tambe, CEO & Managing Director of Biocon Biologics, - The FDA's permission for Bosaya and Aukelso is a start that has international echoes in terms of our goal of making biologics more accessible. Not only do we add to our strengths in the treatment of osteoporosis and oncology, but also our scientific and regulatory leadership is further reinforced by these approvals."

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Both biosimilars met the quality, safety, and effectiveness criteria of their reference products in clinical trials. Bosaya will operate under the same Risk Evaluation and Mitigation Strategy (REMS) as Prolia, indicating that there is a risk for severe hypocalcemia in patients with advanced chronic kidney disease.