Payers’ perspectives on biosimilars in the US: Past, present, and future.

Abstract

e13510 Background: With 10 blockbuster biologics facing patent expiration in the U.S. within the next five years, the oncology therapy area is poised for heightened competition from biosimilars. This influx of biosimilars will intensify competition, propelling the global oncology biosimilar market value to an estimated $35.7 Bn by 2034. Payers' preference for rebates and discounts, strong manufacturer relationships, and reliable supply chains will be key drivers of market dynamics. This qualitative study aimed to understand the anticipated evolution of payer dynamics within U.S. market amidst growing biosimilar competition. Methods: The study began by screening 35 U.S. payers, following which preliminary profiles of 16 payers were received. Based on study’s selection criteria, which included number of lives covered (> 5 Mn for PBM and National MCO; > 0.25 Mn for IDN/IPPN and Regional MCO), experience with biosimilars (> 5 years), influence on formulary (pharmacy director, medical director, formulary managers roles), and strategic alignment with the study's objectives, 10 most suitable decision-makers impacting > 300 Mn U.S. lives, were interviewed. Results: 75% of payers expressed an intention to promptly transition patients from reference products to biosimilars upon their availability, both in existing and new markets, suggesting a departure from their previous "wait and watch" approach 87% expressed confidence in the safety/efficacy of biosimilars, perceiving them to be comparable or equivalent to their respective reference products. This positive perception has evolved over time, driven by their observations of prescribers' comfort in using biosimilars, the FDA's approval and the agency’s use of the "totality of evidence" approach to evaluate biosimilars While net cost remains a key driver for biosimilar adoption, cited by 75% of payers, the importance of interchangeability designation has diminished recently. Instead, strategic portfolio alignment and strong manufacturer relationships are becoming more influential in adoption decisions 87% of payers anticipate that private label arrangements will become the standard in near future, driven by strong manufacturer relationships, supply reliability, and mutually beneficial economic outcomes. Conclusions: The oncology biosimilar market is evolving as major biologics approach patent expiration, leading to increased competition, with factors such as cost-effectiveness and strategic manufacturer collaborations likely to influence the rate of adoption. While payers are expected to continue to play a role in shaping the pace of biosimilar adoption in the future, patients will likely expect transparency, open communication, and shared decision-making. Additionally, upcoming policy changes present both opportunities and challenges for the industry. Navigating the evolving regulatory landscape will be crucial for the continued maturity of the biosimilar market.