OBJECTIVES: Quality of Life (QoL) is important for patients with RA and Enbrel^® has demonstrated QoL benefits in this patient group. HD203 is an etanercept biosimilar, which reported pharmacokinetic bioequivalence to the reference product Enbrel^® in a Phase I trial and, more recently, demonstrated equivalent efficacy and comparable safety in a phase III randomized trial in Korean patients with RA. Assessing QoL was a secondary objective of the HERA study, the results of which are reported here. METHODS: Patients (male or female aged ≥20 years) with active RA were randomized (1:1) to 25 mg HD203 or Enbrel^®, administered subcutaneously twice weekly with MTX for 48 weeks. QoL assessments (Short Form 36, SF-36; Functional Assessment of Chronic Illness Therapy-Fatigue, FACIT-F; EuroQol-5 dimension, EQ5D) were undertaken at weeks 24 and 48. RESULTS: In total, 294 patients were randomized (147 to HD203; 147 to Enbrel^®). There was no significant difference between groups on QoL assessments at baseline. QoL assessments were similar for HD203 and Enbrel^® at week 24 and 48 overall. However, SF-36 Role Emotional and Bodily Pain subscales showed significant increase in favour of HD203 at week 24 (p=0.0252) and week 48 (p=0.0243) respectively. No significant difference was observed between HD203 and Enbrel^® for FACIT-F scores at week 24 or 48, except at week 48 for the Emotional Well-being domain, which was significantly improved with Enbrel^® vs. HD203 (p=0.0360). No significant differences between groups in EQ5D scores were observed at any time. CONCLUSIONS: Together with previous reports of equivalent pharmacokinetics and efficacy, and comparable safety, these data support the biosimilarity of HD203 vs. Enbrel^®