Introduction
Biologics have reshaped the treatment landscape across a broad range of therapeutic areas. They introduced a greater degree of precision and molecular targeting than traditional small molecule therapies. This revolutionised how clinicians approach chronic and complex diseases. From autoimmune conditions to rare haematological diseases, their ability to target specific points in disease pathways has delivered transformative clinical outcomes, establishing biologics as high-value medicines for health systems worldwide.
However, that value comes at a cost. Biologic manufacturing is highly complex, often needing living cell systems, stringent quality controls, and cold-chain distribution. This means that these therapies typically command a significantly higher price than their small molecule counterparts. For health systems managing constrained budgets, the growing reliance on biologics has contributed to the ever-growing tension between clinical benefit and economic sustainability.
The promise of biosimilars and its limits
The introduction of biosimilars following the patent expiration of originator biologics was expected to alleviate some of this pressure. As lower-cost alternatives with comparable efficacy and safety profiles, biosimilars offer health systems the opportunity to maintain clinical standards while generating meaningful cost savings. The expectation was straightforward: biosimilar entry increases competition, which in turn drives the price of the originator molecule down. Yet this relationship does not always appear. Policy frameworks, market structures, and forces outside the pharmaceutical market heavily influence the extent to which biosimilar competition translates into originator price cuts.
In our previous analysis of originator biologic list prices across the US, France, and Germany, we found that in Europe, a higher number of biosimilar competitors led to more originator price erosion post-LoE. This was consistent with the statutory pricing frameworks that directly link pricing outcomes to competition. In the US, biosimilar competition degraded originator pricing power but did not result in absolute price cuts, regardless of the number of competitors.
When the same data is broken down by therapeutic area, a different picture emerges. Not only does the level of biosimilar competition vary significantly between therapeutic areas, but the forces driving post-LoE price changes differ too. This analysis examines these differences with a focus on Endocrinology biologics and Immunology biologics. These sit at opposite ends of the biosimilar competition spectrum. The sharp contrast between these therapy areas reveals that beyond market dynamics, the political visibility of a product plays a significant role in shaping its pricing trajectory.
Method
The analysis covered 18 originator biologic molecules across six therapeutic areas: Immunology, Oncology, Ophthalmology, Rheumatology, Haematology and Endocrinology. The respective biosimilar approval data was extracted from both the FDA and EMA in October 2025. We compared the average year-on-year originator price change in each therapeutic area. The comparison covered the five years before and after LoE across the US, France and Germany.
Biosimilar competitive landscape
Figure 1: Average number of biosimilars approved by the FDA and EMA per originator molecule across six therapeutic areas, from a sample of 18 originator biologics.
Biosimilar competition was more concentrated in certain therapeutic areas, likely reflecting differences in the perceived commercial opportunity for biosimilar developers. Immunology had an average of 5.0 FDA and 8.0 EMA approved biosimilars per originator. Endocrinology sat at the opposite extreme with just 1.5 FDA and 2.5 EMA approved biosimilars (Figure 1). Due to their positioning at opposite extremes, the following sections take a deeper look at the pre- and post-LoE pricing dynamics within these two therapeutic areas.
Immunology vs Endocrinology biologics
Figure 2: Average year-on-year price change in the five years preceding and five years following loss of exclusivity (LoE) for Endocrinology and Immunology originator biologics across the US, France, and Germany.
Key findings on biologic pricing post-LoE
Post-LoE pricing behaves predictably across all three markets for Immunology biologics and in both European Endocrinology biologic markets, where higher biosimilar competition correlates with more price erosion in line with each market’s pricing framework (Figure 2). However, US Endocrinology biologics were an anomaly, with steep price declines occurring despite low biosimilar competition.
How pricing frameworks shape biologics post-LoE
In France, CEPS negotiations set prices based on assessed therapeutic benefit (ASMR rating). Prices face systematic revisions after an initial five-year contract period. A safeguard clause caps total pharmaceutical spending growth, with mandatory clawback payments limiting originator price resilience. In Germany, products enter the market at a freely set price. AMNOG negotiations then fix the price based on clinical effectiveness. Post-LoE, therapeutic reference groups (Festbetragsgruppen) cap reimbursement at a group-specific level. This drives price reductions as manufacturers seek to limit patient out-of-pocket costs. In the US, the absence of statutory price regulation combined with a PBM rebate structure that rewards higher list prices for competitive formulary placement means originator prices typically rise pre-LoE. Post-LoE, biosimilar competition reduces the originator’s price-setting power, though the structural incentive to maintain high list prices persists.
The anomaly of US endocrinology
US Endocrinology biologic price changes did not follow the Immunology trend, where increased biosimilar competition resulted in more price erosion. Within a market-driven system with no automated mechanisms to regulate biologic prices, limited biosimilar competition is expected to allow price growth. Yet Endocrinology biologic prices declined steeply both pre- and post-LoE at -6.15% and -7.50% respectively. This signals the influence of factors outside biosimilar competition.
The role of political visibility in biologic pricing post-LoE
Immunology biologics included therapies such as Humira, one of the highest grossing drugs of all time. It generated over $20 billion in revenue at its peak. Despite this, Humira did not attract significant public scrutiny over its pricing. Institutional payers largely bore the costs, making them less visible to patients at the point of care. The post-LoE pricing dynamic was more market-driven, with biosimilar developers investing heavily given the scale of the revenue opportunity. This was an expected pattern across all three markets.
The Endocrinology biologics largely consisted of Insulin molecules (such as Lantus), one of the most politically visible therapies in the US. This was due to the large patient population needing daily treatment and high out-of-pocket costs from long-term use. The perception of disease severity fuelled public concern around affordability and equitable access. As a result, advocacy groups mobilised, prompting congressional scrutiny and ultimately legislative action. This political pressure shaped the pricing trajectory. It led first to manufacturer-led voluntary price cuts and later to formal policy action under the Inflation Reduction Act. Insulin affordability was instrumental to the legislation’s rollout.
Table 1: Summary of key features distinguishing politicised products from those following standard post-LoE pricing expectations. This was based on the comparison of Endocrinology (e.g. Lantus) and Immunology (e.g. Humira) originator biologics in the sample.
When political pressure overrides market forces
Politicised products attract more institutional scrutiny than the standard expectation (Table 1). In the US, where no automated price erosion mechanism exists, that scrutiny translates into blunt legislative intervention. This marks a departure from the market-driven approach. Without the gradual, systematic frameworks seen in France and Germany, the US correction arrives as an acute shock rather than an incremental erosion. US Endocrinology biologics saw -7.50% post-LoE price decline compared to -3.04% in France and +2.12% in Germany. This political pressure extends beyond biologics to other endocrinology therapeutics. GLP-1s are attracting similar political attention and policy responses, with molecules such as semaglutide approaching LoE in several markets.
Figure 3: White House briefing board displaying the list, retail and Most Favoured Nation (MFN) prices of anti-obesity medications, November 2025. Source: Andrew Harnik/Getty Images
Conclusion: What drives biologic pricing post-LoE
The number of biosimilar approvals in a therapeutic area is only the beginning of the post-LoE price journey. The analysis of Endocrinology and Immunology biologics across the US, France, and Germany demonstrates that the forces shaping biologic pricing after patent expiration extend well beyond competitive dynamics. Three factors determine how far a product can be politicised: patient population size, direct patient cost exposure, and perception of disease severity. These differ significantly across therapeutic areas. Where these factors converge, as with Endocrinology biologics, the resulting political visibility directly influences pre- and post-LoE pricing trajectories. In the US, the absence of automated price erosion mechanisms means political visibility translates into sharp legislative intervention. This often exceeds the gradual erosion delivered by European frameworks.
As budget scrutiny intensifies across major markets, these considerations become increasingly urgent for manufacturers managing biologics approaching LoE. Forecasting biologic pricing post-LoE requires more than counting expected biosimilar competitors. Assessing the political visibility of a biologic and its therapeutic area is essential. Understanding how that visibility interacts with each market’s pricing architecture helps anticipate where and how price erosion will materialise.
Contact Inbeeo to discuss how analysis of policy dynamics can inform your biologic pricing strategy.