Abstract 

Biosimilar approvals have expanded across established regulatory markets, yet patient uptake remains uneven. Although biosimilars typically enter the market at lower list prices than their reference products, the real-world uptake and sustained supply depend on procurement design, distribution, contracting incentives, clinical implementation and supply resilience.

This article examines the post-authorisation barriers through three dimensions: affordability, availability and system readiness. It explores how these barriers may intensify for prospective biosimilar advanced therapy medicinal products (ATMPs), where manufacturing scale, chain-of-identity controls and site readiness constraints are more acute.