OBJECTIVES: To estimate the budget impact of etarnercept biosimilars in the treatment of Rheumatoid Arthritis (RA) within a 3-year time horizon in France, by analyzing a national representative sample of patients. METHODS: The “Échantillon Généraliste des bénéficiaires” (EGB) database is a 1/97 representative sample of the national claims database covering the whole French population. RA patients were identified as adults benefiting from full coverage (“ALD” eligibility criteria) for RA (ICD-10 codes M05-06) from 2010 to 2014. Patients treated with Biologic Agent (BA) were defined as RA patients with at least one claim for at least one BA over the period 2010-2014. Results were extrapolated for France, by applying weights based on age and gender repartition. Market shares and annual treatment costs were estimated in EGB database over the period 2011-2014 and extrapolated from foreseeable trends and expert opinions. Discount of biosimilars was negotiated at 15.9%. Penetration rates of etanercept biosimilars depend mainly on incentive policies and were supposed to reach respectively 20%, 50% and 80% in 2016, 2017 and 2018. RESULTS: Number of RA patients treated with BA increased over time from 31,397 in 2011 to 38,630 in 2014. Most of the patients were treated with etanercept and adalimumab. Without the arrival of biosimilars, the extrapolated expenditure associated to BA in the treatment of RA will increase from 340.7M€ in 2015 to 360.5M€ in 2018. In case of initiation of etanercept biosimilars as first line treatment in BA-naïve patients or after treatment failure in etanercept-naïve patients, the 3-year cumulative budgetary impact is estimated at 9.5M€. If the possibility of switching from ongoing treatment with ENBREL to etanercept biosimilars is authorized, the 3-year cumulative budgetary impact is estimated at 26.6M€. CONCLUSIONS: Budgetary impact of etanercept biosimilars depends mainly on the possibility of switching from ongoing treatment with ENBREL to biosimilars.