OBJECTIVES : The Biologic Price Competition and Innovation (BPCI) Act created abbreviated approval pathways for biosimilars in the US. However, since its implementation, only a limited number of biosimilars are available in the US market and the uptake of biosimilars is slow. This study aims to analyze the obstacles hindering biosimilar availability and uptake in the US.

METHODS : An inventory of FDA-approved biosimilars and reference biologics were assembled. A thorough review of FDA general guidance’s, drug fact sheets, and Truven Health’s Redbook was conducted. FDA approval dates, patent expiration dates, actual/anticipated market availability dates, and pricing of biosimilars and reference biologics were collected and analyzed.

RESULTS : Nine biosimilars have been approved by the FDA for six distinct biological products between 2015 and 2017. Patents have expired for four of the six reference biologics. However, only three biosimilars (filgrastim-sndz, infliximab-dyyb, and infliximab-abdm) are available in the US. The waiting time between FDA approval to actual/anticipated market availability is longer in the US (median: 6 months; range: 3-76 months), as compared to Europe (median: 0 month; range: 0-5 months). Additionally, five biosimilars do not have anticipated market launch dates due to ongoing legal conflicts. Legal disputes, settlements between manufacturers, and patent protections appear to be the principle factors in disrupting US market availability. Biosimilars cost 17% to 35% less than reference biologics in the US (17% for filgrastim-sndz, 19% for infliximab-dyyb, and 35% for infliximab-abdm). Generic small-molecule drugs, however, cost 50% to 80% less than brand-name drugs.

CONCLUSIONS : The US significantly lags in terms of market availability post-exclusivity periods in comparison to that of Europe. The small price discount of biosimilars to reference biologics could have slowed down the uptake of biosimilars in the US market.