Insulin aspart and denosumab biosimilars approved in US

In February 2025, the US Food and Drug Administration (FDA) approved Sanofi-Aventis’ Merilog (insulin aspart-szjj), referencing NovoNordisk’s NovoLog (insulin aspart); and Samsung Bioepis’ Ospomyv and Xbryk (denosumab-dssb), referencing Amgen’s Prolia and Xgeva, respectively. Additionally, the FDA granted a provisional determination of interchangeability designation for both Ospomyv and Xbryk with its reference medicines.

Merilog (Insulin aspart-szjj)
Sanofi-Aventis' Merilog (insulin aspart-szjj) has been approved for improving glycemic control in adults and pediatric patients with diabetes mellitus. It is the first rapid-acting insulin biosimilar to receive FDA authorization, with the decision announced on 14 February 2025.

Insulin aspart is a type of manufactured insulin used to treat type 1 and type 2 diabetes. It has a more rapid onset and a shorter duration of activity than normal human insulins [1].

As a rapid-acting insulin, Merilog helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3 mL single-patient-use prefilled pen and a 10 mLmultiple-dose vial.

Merilog (insulin aspart-szjj) is the third insulin biosimilar product approved by the FDA, joining the two existing long-acting insulin biosimilar products: Eli Lilly’s Rezvoglar (insulin glargine-aglr) and Mylan/Biocon’s Semglee (insulin glargine-yfgn) [2, 3]. Semglee, the first insulin biosimilar approved on 11 June 2020, also became the first to receive the interchangeable status on 28 July 2021 [4], and Rezvoglar was approved on 17 December 2021, also holds interchangeable status.

Ospomyv and Xbryk (denosumab-dssb)
Samsung Bioepis’ Ospomyv and Xbryk/SB16 (denosumab-dssb) was approved by the FDA on 13 February 2025.

Denosumab is a humanized monoclonal antibody that is an inhibitor of the receptor activator of nuclear factor kappa-B ligand (RANKL), which works by preventing the development of osteoclasts which are cells that break down bone. It is used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone and giant cell tumour of bone [5].

Ospomyv, referencing Prolia, has been approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture, treatment to increase bone mass in men with osteoporosis at high risk for fracture, treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer and for the treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Xbryk, referencing Xgeva, has been approved for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumours, 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 for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

The FDA approval of SB16 was based on totality of evidence including analytical, non-clinical data, and clinical data. A Phase 1 study confirmed pharmacokinetic (PK) equivalence between SB16, EU-sourced, and US-sourced denosumab in healthy males. A Phase 3 study showed equivalent efficacy, safety, immunogenicity, PK, and pharmacodynamics (PD) between SB16 and reference denosumab in postmenopausal osteoporosis patients. Primary endpoints, including lumbar spine bone mineral density changes at 12 months, were met, with comparable results up to 18 months.

Ospomyv is marketed as Obodence in Europe where it was approved in January 2025 [6]. Ospomyv will be available in a 60 mg pre-filled syringe, while Xbryk, will be available in 120 mg vial.

LATIN AMERICAN FORUM
The objective of GaBI’s Latin American Forum is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: Biosimilares en países de ingresos bajos y medios

Browse the news in the Latin American Forum!

FORO LATINOAMERICANO
El objetivo del Foro Latinoamericano de GaBI es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: Biosimilares en países de ingresos bajos y medios

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of insulin aspart [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 12]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-insulin-aspart
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab and insulin glargine biosimilars Yusimry and Rezvoglar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 12]. Available from: www.gabionline.net/biosimilars/news/fda-approves-adalimumab-and-insulin-glargine-biosimilars-yusimry-and-rezvoglar
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves insulin glargine biosimilar Semglee [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 12]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-insulin-glargine-biosimilar-Semglee
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 12]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-insulin-glargine-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of denosumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 12]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab
6. GaBI Online - Generics and Biosimilars Initiative. EC approves eight biosimilars, eight more await final authorization [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 12]. Available from: www.gabionline.net/biosimilars/news/ec-approves-eight-biosimilars-eight-more-await-final-authorization

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.