The FDA recently approved a ‘2fer’, two biosimilars for the same reference therapy. The two in question are Bosaya and Aukelso, denosumab biosimilars for all indications of Amgen’s Prolia and Xgeva. Both biosims are from Biocon Biologics Ltd. The FDA also granted provisional interchangeability designation for both biosimilars reinforcing their use for all FDA-approved indications of the reference products.
Denosumab, a human monoclonal antibody, supports bone resorption and reduces bone breakdown to increase bone mass and strength. It is most commonly used to treat osteoporosis in women to prevent fractures following menopause (Prolia) and prevent spinal cord compression or the need for radiation/surgery to the bone in patients with multiple myeloma and bone metastases from tumors (Xgeva).
These biosimilars add to an expanding roster of approved competitors. Notably, each new approval introduces two additional ‘branded biosimilar names’ to the market.
The company did not disclose pricing information, nor did it provide details regarding distribution plans for the therapies.
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