Year in Review: FDA Expands Biosimilar Approvals Across Oncology, Immunology, and Bone Health

In 2025, the FDA continued its expansion of the US biosimilar landscape, with recent approvals spanning osteoporosis, oncology, immunology, rheumatology, and ophthalmology, reflecting growing confidence in biosimilars as safe, effective, and more accessible alternatives to reference biologics.

In addition to approvals, several received interchangeability designations that further support pharmacy-level substitution. These developments signal meaningful progress in broadening treatment options, improving affordability, and increasing flexibility for health care providers and patients across a range of chronic and serious diseases.

Prolia and Xgeva Biosimilars

This year, the FDA approved multiple of biosimilars referencing denosumab (Prolia, Xgeva; Amgen) for the treatment of osteoporosis- and cancer-related bone loss. These include:

• denosumab-dssb 120-mg vial (Xbryk; Samsung Bioepis Co) and denosumab-dssb 60-mg prefilled syringe (Ospomyv; Samsung Bioepis Co)¹;
• denosumab-bmwo (Stoboclo, Osenvelt; Celltrion USA), which later received an interchangeability designation in October 2025^2,3;
• denosumab-bnht (Conexxence, Bomyntra; Fresenius Kabi), which also received interchangeability designations in October 2025^4,5;
• denosumab-nxxp injection 60 mg/mL (Bildyos) and denosumab-nxxp 120 mg/1.7 mL (Bilprevda; Shanghai Henlius Biotech, Organon)⁶;
• denosumab-kyqq 60 mg/mL subcutaneous injection (Bosaya) and denosumab-kyqq 120 mg/1.7 mL (70 mg/mL) subcutaneous injection (Aukelso; Biocon Biologics Ltd.), which simultaneously received interchangeability designations⁷; and
• denosumab-desu (Osvyrti, Jubereq; Accord BioPharma).⁸

Xbryk, Stoboclo, Conexxence, Bilydos, Bosaya, and Osvyrti are approved for the same indications as Prolia, which include the treatment of^1-8:

• postmenopausal women with osteoporosis who are at a high risk of fracture
• men with osteoporosis who are at a high risk of fracture and need to increase bone mass
• men and women with glucocorticoid-induced osteoporosis who are at a high risk of fracture
• men receiving androgen deprivation therapy for nonmetastatic prostate cancer who are at a high risk of fracture and need to increase bone mass
• women receiving adjuvant aromatase inhibitor therapy for breast cancer who are at a high risk of fracture and need to increase bone mass.

Ospomyv, Osenvelt, Bomyntra, Bilprevda, Aukelso, and Jubereq are approved for the same indications as Xgeva, which are the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors; treatment of 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 treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.^1-8

Stelara Biosimilars

Starjemza

Ustekinumab-hmny (Starjemza; Bio-Thera Solutions, Hikma Pharmaceuticals) received FDA approval as a biosimilar to ustekinumab (Stelara; Janssen Biotech), based on extensive nonclinical and clinical evidence demonstrating comparable efficacy, safety, immunogenicity, and quality. Starjemza, like its reference product, is a monoclonal antibody that inhibits IL-12 and IL-23 signaling, key drivers of inflammatory diseases such as psoriasis, psoriatic arthritis (PsA), and inflammatory bowel disease. Approval was supported by phase 3 trial data in patients with moderate to severe plaque psoriasis showing similar improvements in Psoriasis Area and Severity Index (PASI) scores, as well as phase 1 data in healthy volunteers confirming comparable pharmacokinetics and safety.⁹

Read more about the Starjemza approval here.

Steqeyma

Ustekinumab-stba (Steqeyma; Celltrion), a biosimilar to Stelara available in a 45-mg/0.5-mL single-dose subcutaneous formulation, received FDA approval in June 2025 for the treatment of plaque psoriasis and PsA in pediatric patients aged 6 to 17 years who weigh less than 60 kg. The decision was based on the FDA’s totality-of-evidence approach, including phase 3 trial data demonstrating comparable efficacy, safety, pharmacokinetics, and immunogenicity to the reference product, with similar improvements in PASI scores and consistent outcomes after switching. The new pediatric-specific dosage provides clinicians with greater flexibility and broadens access to biologic therapy for children with chronic inflammatory conditions.

The decision, along with Starjemza’s approval, adds to a growing number of FDA-approved Stelara biosimilars, expanding treatment options for patients with immune-mediated conditions.¹⁰

Read more about the Steqeyma approval here.

Actemra, Eylea, and Poherdy Biosimilars

Avtozma, an Actemra Biosimilar

Tocilizumab-anoh (Avtozma; Celltrion), a biosimilar referencing tocilizumab (Actemra; Genentech) in both intravenous and subcutaneous formulations, was approved by the FDA for multiple indications, including rheumatoid arthritis (RA), giant cell arteritis, several forms of juvenile idiopathic arthritis, and COVID-19. The approval was supported by a totality of evidence that included a phase 3 randomized study in patients with moderate to severe active RA, which demonstrated comparable efficacy and safety between the biosimilar and the reference product when used with methotrexate. Conducted across 22 centers in Poland, the trial demonstrated that Avtozma met primary end points for improvement in Disease Activity Score-28 for Rheumatoid Arthritis with ESR at weeks 12 and 24, with similar improvements across secondary disease activity measures and consistent outcomes in patients who continued or switched from the reference product.¹¹

Read more about the approval here.

Eydenzelt, an Eylea Biosimilar

Aflibercept-boav (Eydenzelt; Celltrion), a biosimilar referencing aflibercept (Eylea; Regeneron, Bayer HealthCare), received approval for the treatment of several serious retinal diseases, including neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema (DME), and diabetic retinopathy. Eydenzelt is an intravitreal VEGF inhibitor that blocks VEGF-A and placental growth factor to reduce abnormal blood vessel growth and fluid leakage in the eye. Its approval was supported by a 52-week phase 3 randomized trial (NCT04739306) in patients with DME, which demonstrated equivalent efficacy, safety, pharmacokinetics, and immunogenicity compared with is reference product, including similar improvements in visual acuity. The approval expands treatment options for health care providers and patients.¹²

Read more about the Eydenzelt approval here.

Poherdy, a Perjeta Biosimilar

Pertuzumab-dpzb (Poherdy; Shanghai Henlius Biologics), the first interchangeable biosimilar to pertuzumab (Perjeta; Genentech), received FDA approval for use in HER2+ breast cancer. Poherdy is a HER2/neu receptor antagonist administered intravenously and is indicated in combination with trastuzumab (Herzuma; Celltrion, Teva Pharmaceuticals) and chemotherapy for adults with HER2+ metastatic breast cancer, as well as for neoadjuvant and adjuvant treatment of high-risk early or locally advanced disease. The interchangeability designation confirms that Poherdy is highly similar to Perjeta with no clinically meaningful differences in safety, purity, or potency, allowing pharmacy-level substitution subject to state law. The approval expands access to HER2-targeted therapy for a breast cancer subtype that accounts for roughly 20% of diagnoses and is associated with higher recurrence risk and poorer outcomes.¹³

Read more about the Poherdy approval here.

REFERENCES

1. Halpern L. FDA Approves Biosimilar Denosumab-dssb to Treat Osteoporosis-, Cancer-Related Bone Loss. Pharmacy Times. February 17, 2025. Accessed December 19, 2025. https://www.pharmacytimes.com/view/fda-approves-biosimilar-denosumab-dssb-to-treat-osteoporosis--cancer-related-bone-loss

2. Ferruggia K. FDA Approves Biosimilars Referencing Denosumab for Osteoporosis-, Cancer-Related Skeletal Events. Pharmacy Times. March 4, 2025. Accessed December 19, 2025. https://www.pharmacytimes.com/view/fda-approves-biosimilars-referencing-denosumab-for-osteoporosis--cancer-related-skeletal-events

3. McGovern G. FDA Grants Interchangeability Designation to Denosumab Biosimilars Stoboclo and Osenvelt. Pharmacy Times. October 30, 2025. Accessed December 19, 2025. https://www.pharmacytimes.com/view/fda-grants-interchangeability-designation-to-denosumab-biosimilars-stoboclo-and-osenvelt

4. Ferruggia K. Denosumab-bnht Biosimilar Receives FDA Approval. Pharmacy Times. March 27, 2025. Accessed December 19, 2025. https://www.pharmacytimes.com/view/denosumab-bnht-biosimilar-receives-fda-approval

5. McGovern G. Denosumab Biosimilars Conexxence and Bomyntra Receive Interchangeability Designation. Pharmacy Times. October 30, 2025. Accessed December 19, 2025. https://www.pharmacytimes.com/view/denosumab-biosimilars-conexxence-and-bomyntra-receive-interchangeability-designation

6. McGovern G. FDA Approves Bildyos and Bilprevda, Biosimilars of Reference Denosumab. Pharmacy Times. September 2, 2025. Accessed December 19, 2025. https://www.pharmacytimes.com/view/fda-approves-bildyos-and-bilprevda-biosimilars-of-reference-denosumab

7. FDA Approves Bosaya and Aukelso, Biosimilars to Reference Denosumab. Pharmacy Times. September 17, 2025. Accessed December 19, 2025. https://www.pharmacytimes.com/view/fda-approves-bosaya-and-aukelso-biosimilars-to-reference-denosumab

8. McGovern G. FDA Approves Denosumab Biosimilars, Osvyrti and Jubereq, for Reference Products’ Indications. Pharmacy Times. November 20, 2025. Accessed December 19, 2025. https://www.pharmacytimes.com/view/fda-approves-denosumab-biosimilars-osvyrti-and-jubereq-for-reference-products-indications

9. Halpern L. FDA Approves Ustekinumab-hmny Injection, a Biosimilar Referencing Stelara. Pharmacy Times. May 28, 2025. Accessed December 19, 2025. https://www.pharmacytimes.com/view/fda-approves-ustekinumab-hmny-injection-a-biosimilar-referencing-stelara

10. McGovern G. FDA Approves Ustekinumab-Stba, Biosimilar to Stelara, for Pediatric Patients With PsO or PsA. Pharmacy Times. June 16, 2025. Accessed December 19, 2025. https://www.pharmacytimes.com/view/fda-approves-ustekinumab-stba-biosimilar-to-stelara-for-pediatric-patients-with-pso-or-psa

11. Gallagher A. FDA Approves Tocilizumab-Anoh as a Biosimilar to Actemra. Pharmacy Times. January 31, 2025. Accessed December 19, 2025. https://www.pharmacytimes.com/view/fda-approves-tocilizumab-anoh-as-a-biosimilar-to-actemra

12. Ferruggia K. FDA Approves Celltrion’s Eydenzelt, Biosimilar to Aflibercept, to Treat Ocular Conditions. Pharmacy Times. October 10, 2025. Accessed December 19, 2025. https://www.pharmacytimes.com/view/fda-approves-celltrion-s-eydenzelt-biosimilar-to-aflibercept-to-treat-ocular-conditions

13. McGovern G. FDA Approves Poherdy, First Biosimilar to Perjeta, For HER2 Breast Cancer Indications. Pharmacy Times. November 13, 2025. Accessed December 19, 2025. https://www.pharmacytimes.com/view/fda-approves-poherdy-first-biosimilar-to-perjeta-for-her2-breast-cancer-indications