EMA Authorised: Evfraxy (denosumab) — Biosimilar Collaborations Ireland Limited

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Summary

EMA authorised Evfraxy (denosumab) as a biosimilar; it is approved for bone resorption disorders including osteoporosis and postmenopausal osteoporosis.

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Diseases / indications

• Osteoporosis
• Postmenopausal Osteoporosis

Drugs mentioned

• Evfraxy (denosumab)

Snippet

Status: Authorised. Therapeutic area: Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal. MAH: Biosimilar Collaborations Ireland Limited. Decision date: 18/02/2026