The study “The Price Effects of Biosimilars in the United States” evaluates how biosimilars price competition impacts pricing in the U.S. pharmaceutical market. It focuses on Medicare Part B average sales price (ASP) dynamics from 2015 to 2023 across eight biologic product markets. The research demonstrates that each additional biosimilar competitor reduces originator product prices by 10-13%. Also, decreases in market concentration of 10% lead to a 1.8% reduction in originator prices. This generates substantial savings for Medicare while raising concerns about long-term market sustainability.

Competitive Forces Driving Prices Down

The study reveals that the U.S. biosimilars market has become highly competitive over time. Price effects have strengthened significantly since earlier research. While a 2022 study found biosimilar competition reduced prices by 5.4-7%, this updated research shows much stronger effects, with 10-13% price reductions per competitor. This acceleration in biosimilars price competition indicates the maturing biosimilar market is effectively functioning to drive down costs.

Reference product prices experienced dramatic unadjusted price falls between 10% and 77% over the nine-year study period. Significant market share shifts away from originators accompanied these declines. The weighted average sales price ratios (accounting for all competitors) decreased between 13-17%, highlighting how biosimilar market entry benefits the entire product category through price competition. These substantial price decreases have contributed to an estimated $23.6 billion in biologic cost savings for the U.S. healthcare system from 2015 to 2023.

The study’s use of the Herfindahl-Hirschman index (HHI) to measure market concentration provides valuable insights beyond simple competitor counts. Results show a 10% decrease in market concentration at the lowest observed HHI leads to price ratio declines of 1.8-2.5%. This finding is significant for policymakers. It demonstrates that not just the number of competitors but the distribution of market share influences pricing dynamics.

Evaluating Market Sustainability

The study raises important concerns about whether the current aggressive biosimilars price competition is sustainable. With year-on-year price declines exceeding 20% for many products—and prices up to 90% below baseline in some cases—there’s a legitimate risk to market sustainability if these trends continue. This aligns with industry perspectives that warn of a potential “biosimilars void” if current market conditions persist.

The findings also suggest that while competition is effectively reducing prices in the short term, policymakers should consider the long-term implications for market stability. Recent congressional hearings have highlighted biosimilars as a critical solution to the nation’s healthcare spending. Key barriers to wider adoption, include restrictive pharmacy benefit management practices, inadequate reimbursement, and limited awareness.

Future Market Trends and Challenges

If near-term biosimilar price declines result in fewer manufacturers entering or remaining in the market, the reduction in competition could paradoxically drive mid to long-term price increases. This potential unintended consequence warrants continued exploration. It may require policy interventions to balance short-term savings with long-term market stability.

The study notes that the Inflation Reduction Act increased the add-on payment for biosimilars from 6% to 8% of the reference product ASP. This represents one policy approach to incentivize biosimilar utilization. However, more comprehensive policy reforms may be needed to address market sustainability. These include streamlining approvals, improving provider and patient education, curbing anticompetitive contracting, and aligning policy with biosimilar development timelines.

In conclusion, while the U.S. biosimilar market has demonstrated remarkable success in driving down prices and generating substantial savings, a delicate balance exists. Promoting competition must be weighed against ensuring long-term market sustainability, requiring thoughtful policy consideration moving forward. For more detailed insights, you can access the full study here.