Therapy Areas: Autoimmune
Sandoz presents new data for biosimilars in RA
15 June 2018 -

Sandoz, a division of Novartis (VTX: NOVN), has presented the findings for two long-term, Phase III biosimilar studies investigating Zessly (infliximab) and Erelzi (etanercept) in rheumatoid arthritis, the company disclosed on Friday.

The REFLECTIONS B537-02 study was a Phase III, double-blind, parallel-group, confirmatory study evaluating Zessly versus reference medicine Remicade (infliximab) in combination with methotrexate in 650 biologic-naïve, adult patients with moderately to severely active rheumatoid arthritis who had an inadequate response to methotrexate therapy alone.

Safety, efficacy and quality of the biosimilar matched its reference biologic. The study met its primary endpoint of a >=20% improvement in American College of Rheumatology (ACR) response at Week 14. Between Week 30 and Week 54, there were no clinically-meaningful differences in terms of safety, efficacy and immunogenicity between those on Zessly and those receiving the reference medicine. The same results were found when patients were blindly re-randomised to switch therapies.

Meanwhile, EQUIRA was a 48-week, randomised, double-blind Phase III study that compared the efficacy and safety of the company's biosimilar Erelzi against the reference Enbrel etanercept. It involved a total of 376 adults with moderate to severe rheumatoid arthritis. It aimed to evaluate the effects of switching from reference etanercept to Sandoz's etanercept

The results showed that there is no effect to overall therapy outcome, in terms of efficacy, safety and immunogenicity, when switching patients from the reference etanercept to Sandoz's biosimilar.