Biosimilars were expected to widen access to biologic medicines by introducing competition into some of the most expensive areas of therapy. In many parts of the world, they have done exactly that, but for others the deeper access problem remains unresolved. A biosimilar can clear regulatory review and reach the market but still fail to expand access meaningfully if the cost of manufacturing keeps prices persistently high. The gap between availability and real affordability is especially pronounced in emerging markets, where a high burden of disease combined with constrained healthcare spending leaves many patients unable to access treatment.

To counter this, the next phase of biosimilars must incorporate different ways of manufacturing facility design as well as product development. For biologics to reach more patients, affordability must be built into the production system itself.

The Limitations of Fed-Batch Processing

Biologics manufacturing has long relied on fed-batch processing, a model that has enabled many important therapies but remains constrained by scale, time, labour intensity and the inefficiencies of moving through separate upstream and downstream stages. Even where process optimisation has improved yields, the underlying process remains resource intensive. As demand for complex biologics rises, this model limits the ability to operate cost‑efficiently, therefore preventing biosimilars from achieving their full public health promise.