The U.S. biosimilars market has reached a critical juncture a decade after the FDA's landmark approval of Zarxio, the first biosimilar in the United States. While these biological copies have delivered substantial cost savings, their impact varies significantly across different market segments and therapeutic areas.
Market Performance and Cost Savings
Industry experts report that biosimilars have generated $36 billion in savings for the U.S. healthcare system. However, Thomas Newcomer, MBA, Vice President at Samsung Bioepis, notes that while significant, these savings fall short of initial expectations: "Have they made a difference? Absolutely. Have they made a difference to the level where we would expect? I would say no."
Current data from Samsung Bioepis reveals that biosimilars have captured an average 53% market share within five years of launch. The success varies dramatically by product - bevacizumab biosimilars have secured 89% market share, while epoetin alfa biosimilars remain at just 37% after seven years.
PBM Influence and Market Access
The pharmacy benefit manager (PBM) landscape has emerged as a crucial factor in biosimilar adoption. Craig Burton, MBA, Executive Director of the Biosimilars Council, points to the significant influence of the "big three" PBMs - CVS Caremark, Optum Rx, and Express Scripts - in determining market access.
A notable example occurred in early 2024 when CVS Caremark removed brand-name Humira from its main formularies, demonstrating PBMs' market-shaping power. "It shows the power of the PBM once it decides that it's in their interest to convert patients," Burton explains.
Medical Benefit vs. Pharmacy Benefit Dynamics
Biosimilar adoption patterns differ significantly between medical and pharmacy benefits. Steven Lucio, Pharm.D., from Vizient, notes stronger uptake in provider settings: "Management has been a little more able to advance and make those decisions where pharmacists work with doctors."
Future Challenges and Opportunities
The market faces new tests in 2025 with the anticipated launch of seven biosimilars for Stelara and new entries in the rare disease space. Samsung Bioepis's Newcomer suggests that rare disease biosimilars may face unique challenges: "Biosimilars are going to be brand-new for a lot of these specialists. We may be going back to a point in time where you are showing the equivalency of a biosimilar to an originator molecule."
Pricing and Access Considerations
Price differences between biosimilars and reference products don't always correlate with market share. For instance, Remicade biosimilars show a 79% price reduction despite holding only 49% market share. The gap between wholesale acquisition costs (WAC) and average sales prices also affects patient access, as insurance copayments often reference WAC prices rather than discounted rates.
Industry stakeholders emphasize the need for increased awareness among employers and payers about biosimilar benefits. Newcomer advocates for greater involvement of benefits consultants: "There are discussions that need to start happening in that sector that will bring better awareness to all of this."
