Exclusive Summary

• • Patents expired; EU has had biosimilars since 2007 and the US since 2018, making global procurement acceptance high.
• • Strong, steady demand in CKD/dialysis: around 4,000,000 dialysis patients worldwide with 80–90% needing ESAs, plus millions in non-dialysis CKD and chemo-induced anemia.
• • WHO EML listing and KDIGO/ASCO-ASH guidelines endorse its role; the 4000 IU strength fits common initiation/maintenance dosing and tender specs.
• • Typical price cuts vs originators are 30–50%, reaching 60–70% in tenders; TT/localization can further reduce landed costs.
• • Quality aligned to US/EU recombinant DNA monographs supports biosimilar registration and multi-market compliance, enabling rapid distribution and TT partnerships.

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