Breaking Barriers: Essential Reforms for a Competitive and Affordable Biosimilars Market.

Abstract

Purpose of review: This update examines the current policy landscape for biosimilars, particularly those approved for treating rheumatoid arthritis. We review recent literature and recommend policies to align the biosimilars market with the goals of the Biologic Price Competition and Innovation Act (BPCIA). We examine updated evidence on biosimilar safety and effectiveness, recent FDA guidance on interchangeability, and challenges posed by anti-competitive behaviors and government regulations. Additionally, we analyze financial incentives and market dynamics affecting biosimilar adoption and competition.

Recent findings: Building on the extensive body of RCT data demonstrating the safety and effectiveness of biosimilars, real-world evidence from North America and Europe now confirms these findings, including in patients who switched therapies. Increased biosimilar prescribing will depend on disseminating safety data and strategies to enhance patient-physician communication. The FDA updated its interchangeability guidance to no longer require large clinical studies, citing updated understanding of safety data; this may facilitate more direct price-based competition. Congress and the Federal Trade Commission need to address anticompetitive behaviors including patent law loopholes, the role of PBMs in inflating drug prices, vertical integration of healthcare conglomerates, and changes to funding for government agencies charged with reviewing biosimilar drugs. Medicare reimbursement rates and the 340B program still unfairly incentivize use of bio-originator products. There are many barriers to achieving the goals of the BPCIA. With necessary changes, the U.S. can realize the goal of a competitive and sustainable biosimilar market that gradually reduces total drug expenditures and out-of-pocket costs over time without stifling innovation.