FDA Biosimilar Product Approvals

Boncresa biosimilar to Prolia approved for osteoporosis

FDA approved Boncresa (denosumab-b00) as a biosimilar to Prolia (denosumab), providing a new treatment option for patients with osteoporosis. The product is indicated for postmenopausal women, men, and patients with glucocorticoid-induced osteoporosis at high risk for fracture, as well as bone loss from hormone ablation therapy for cancer. Boncresa is administered as a 60 mg subcutaneous injection every 6 months.

Oziltus Biosimilar to XGEVA Approved for Bone Metastases and Multiple Myeloma

FDA approved Oziltus (denosumab-mobz), a biosimilar referencing XGEVA (denosumab), for prevention of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors. The drug is also approved for giant cell tumor of bone and hypercalcemia of malignancy. Marketed by Amneal Pharmaceuticals LLC, this approval expands treatment options for bone-related oncology conditions.

FDA Approval of JUBEREQ and OSVYRTI (denosumab-desu)

The FDA has approved Biologic License Application (BLA) 761424 for JUBEREQ and OSVYRTI, both containing the active ingredient denosumab-desu, submitted by ACCORD BIOPHARMA INC. This approval marks the addition of new prescription injectable medications to the market.

FDA Approves ARMLUPEG (Pegfilgrastim-unne) Biosimilar

The FDA has approved ARMLUPEG (pegfilgrastim-unne), a biosimilar drug manufactured by LUPIN LTD. This approval marks the addition of a new biosimilar product to the market, following the FDA's review process.

FDA Approves Ranibizumab-leyk Biosimilar (NUFYMCO)

The FDA has approved the Biologic License Application (BLA) 761473 for NUFYMCO (ranibizumab-leyk) from FORMYCON AG. This approval marks the addition of a new biosimilar product to the market.

FDA Approves Filgrastim-LAHA Biosimilar

The FDA has approved FILKRI (filgrastim-LAHA), a biosimilar product, for ACCORD BIOPHARMA INC. The approval was granted on January 15, 2026, under Biologic License Application (BLA) 761027. This marks the addition of a new biosimilar option to the market.