At its November meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorizations for two biosimilar medicines that address high-burden, chronic diseases: Ondibta (insulin glargine, Gan & Lee Pharmaceuticals Europe GmbH) for type 1 and type 2 diabetes, and Osqay (denosumab, Theramex Ireland Ltd) for osteoporosis and associated fracture risk.

Both products now advance to European Commission review. If authorized, they are expected to expand access to effective, lower-cost biologic therapies for clinicians and patients across the European Union (EU).

Ondibta

Ondibta is a biosimilar to the reference product Lantus SoloStar (Sanofi), authorized in the EU in 2000. 

In phase 3 studies involving more than 1100 participants with type 1 and type 2 diabetes, Ondibta demonstrated comparable efficacy, safety, immunogenicity, and pharmacokinetic profiles vs the reference insulin glargine. Additional pharmacokinetic and pharmacodynamic evidence derived from glucose clamp studies, including a comparative evaluation of Gan & Lee’s insulin glargine U300 with the reference Toujeo (Sanofi), further supported biosimilarity.

Ondibta will be available as a 100 units/mL solution for injection in a prefilled pen and is intended for the treatment of diabetes in adults, adolescents, and children aged 2 years or older.

Osqay

Osqay is a biosimilar to Prolia (denosumab), which was authorized in the EU in 2009. Across comparability studies, Osqay matched the reference product in quality, safety, and efficacy, fulfilling EMA biosimilarity criteria.

The active substance, denosumab, is a monoclonal IgG2 antibody that binds to RANKL, a signaling protein that activates bone-resorbing osteoclasts, blocking its interaction with the NF kappa B receptor activator RANK and inhibiting osteoclast formation and activity. This reduces bone resorption in cortical and trabecular bone.

Osqay will be supplied as a 60 mg solution for injection in a prefilled syringe. 

The CHMP opinion covers multiple indications for the biosimilar product linked to fracture risk, including:

• Osteoporosis in postmenopausal women at increased fracture risk
• Bone loss from hormone-ablation therapy in men with prostate cancer at increased fracture risk
• Glucocorticoid-induced bone loss in adults at increased fracture risk

Final decisions from the European Commission are pending. Once authorized, the summary of product characteristics, package leaflets, and assessment reports will be published in all official EU languages.