OBJECTIVES: Biologic disease modifying anti-rheumatic drugs (bDMARDs) are designed to inhibit a specific component of the immune response that fuels inflammation, the predominate manifestation of rheumatoid arthritis (RA). Between 1998 and 2012 ten bDMARDs gained approval for treatment of RA in the U.S. In the past 15 months 4 biosimilars have gained FDA approval, as has one branded bDMARD, sarilumab, on 05/2017. The goal of this study is to evaluate the market uptake of new bDMARDs and the impact of biosimilars’ approval on market trends.

METHODS: Symphony Health longitudinal prescription and medical claims data was used to assess market share of all FDA-approved biologics indicated for RA from 01/2012 to 03/2017 and was parsed by quarter.

RESULTS: Etanercept and adalimumab had a combined 79% market share in Q1 2012, declining to 77% in the quarter in which tofacitinib was launched, Q4 2014; and further steadily eroding to 64% by the quarter in which infliximab-dyyb launched, Q4 2016. Tofacitinib has gained modest uptake since approval with the most recent share at 9%. Total utilization of biologics has remained relatively unchanged from 2012 to present. The first launched biosimilar infliximab-dyyb has had a very mild uptake: <1% share (78 patients) in Q1 2017.

CONCLUSIONS: bDMARD use in RA remains concentrated with two clear market leaders, etanercept and adalimumab despite branded and biosimilar competitors. Etanercept’s and adalimumab’s market share steadily declined after the new entry launch of tofacitinib. Biosimilars’ market effects have thus far been negligible, and likely related to launch delays. Further research is needed to assess what effect the newly-approved biosimilars and sarilumab may have on the RA biologics’ market.