Presentation (CTI)

OBJECTIVES: The Biologics Price Competition and Innovation Act (BPCIA) was an important component of the 2010 Affordable Care Act. It was meant to smooth the path for biosimilars to enter the market, inspired by the long-term success of small-molecule generics in delivering value to US patients and the healthcare system more broadly. Several factors have led to relatively slow development of the US biosimilars market. We examine whether recent developments in the market and forecasted biosimilar launches reflect a need for major changes to the BPCIA or reflect that the law is working as intended.
METHODS: We gathered annual sales data for major biologics (those achieving peak sales of eat least $200 million) from 2013 through 2023 from IQVIA and Medicare and calculate the share of biologic sales each year for which an approved biosimilar is available on the market (inclusive of biosimilar sales). We also calculate the effective patent life for each medicine, the weighted average number of years since launch for those products that do not have a biosimilar.
RESULTS: The share of biologic sales nationally for major products with an available biosimilar has risen from 4.1% in 2013 to 18.8% in 2023. We estimate that in 2023, 13.4% of Medicare sales were for products with biosimilar competition, forecasted to rise to 21.2% in 2024 and 29.8% in 2025 . The average major biologic without biosimilar competition had been on the market 12.6 years in 2013, falling to 10.7 years in 2023.
CONCLUSIONS: The BPCIA has taken a decade to take hold but now appears to be accelerating biosimilar approvals. Reimbursement, coverage and other commercial factors present separate challenges from the fundamental mechanism of approval which appears to be working as intended.