The Biosimilar Boom That’s Rewriting U.S. Pharma

US payers drive biosimilar boom, pressuring fermentation drug makers to cut costs and boost domestic capacity.

1 Aug 2025

US insurers and pharmacy benefit managers are accelerating the shift to biosimilars, using formulary controls, interchangeability approvals and tiered pricing to lower drug costs and reshape the biologics market.

A July 2025 report from Evernorth found that Humira’s unit costs fell 34.4 per cent between the first quarter of 2024 and the end of the year. Biosimilars delivered more than $200mn in savings from January 2024 to March 2025, according to the study.

The trend is being reinforced by new US Food and Drug Administration approvals for biosimilar versions of drugs including ustekinumab and bevacizumab, with candidates for denosumab and eculizumab under review.

Lower prices are narrowing margins for manufacturers of fermentation-based biologics such as insulin analogues and enzymes. In response, companies are upgrading fermentation systems, shortening production cycles, and integrating research and manufacturing to maintain competitiveness.

Some producers are also moving closer to US consumers. Contract development and manufacturing organisations such as AGC Biologics and Lonza have reported growing interest from drug makers seeking quicker turnaround, reserve capacity and alignment with domestic regulatory standards. While not yet industry-wide, such partnerships are increasingly viewed as a way to secure contracts in a market where speed and efficiency are decisive.

Smaller companies are adjusting strategies as well. Harrow’s acquisition of ophthalmology biosimilars from Samsung Bioepis highlights the appeal of niche markets with steady demand. However, these players face similar pricing and supply chain pressures as larger rivals.

Analysts warn that inefficient producers may be forced out and that reliance on a small number of manufacturing hubs could heighten supply risks. Yet they also expect the competitive squeeze to spur innovation in fermentation-based drug production, expanding access to essential medicines at lower cost.

In a market defined by rapid change, analysts say success will depend on the ability to produce high-quality biosimilars quickly and reliably, as manufacturing capability becomes as critical as the medicines themselves.