LusiNEX is Mycenax’s tocilizumab, biosimilar version of RoActemra® (in Europe) / Actemra® (in USA), and the humanized monoclonal antibody IgG1 targeted interleukin-6 receptor (IL-6R). By binding IL-6R, it blocks the inflammatory response and joint erosion.
Tocilizumab is indicated for RA, active polyarticular juvenile idiopathic arthritis (PJIA), systemic juvenile idiopathic arthritis (SJIA) and castleman’s disease.
As the only non-TNF antagonists among the first-line therapeutics for RA, tocilizumab demonstrated outstanding efficacy, and offered the alternative for treating RA. With LusiNEX and TuNEX®, Mycenax can provide the sound portfolio for patients suffered from RA or other related autoimmune diseases.
The development of LusiNEX followed the regulatory pathway of biosimilar, with high biosimilarity to its reference product, and complied with the requirements of European Medicine Agency. This project is granted by Ministry of Economic Affairs (MOEA) and selected as the critical path project by Center for Drug Evaluation (CDE) in Taiwan.
LusiNEX is under process development now and is expected to initiate phase I trial in 2017 in Europe and Taiwan.