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.
Diamyd Medical granted US FDA Fast Track designation for Diamyd diabetes treatment
Ono partners with Shattuck Labs for bifunctional fusion proteins
Artax Biopharma doses first subject in AX-158 Phase 2a psoriasis trial
Bio-Thera Solutions commences dosing in BAT6026 Phase IA/IIB clinical trial
BioSenic expands patent coverage for ATO therapeutic platform
Celltrion USA submits CT-P47 Biologics License Application to FDA
NS Pharma's NS-229 receives European Commission orphan drug designation
Kyverna Therapeutics' KYV-101 granted US FDA fast track designation
InnoCare Pharma receives U.S. FDA clearance for ICP-248 clinical trial
Biosenic finalises agreement with Phebra for oral arsenic troxide development
Guangzhou Fermion Technology's FZ008-145 IND application receives Chinese regulatory approval
Allorion Therapeutics signs exclusive option and global license agreement with AstraZeneca