Date: 2016-02-14
Type of information: Clinical trial autorization
phase: 3
Announcement: clinical trial authorization
Company: JHL Biotech (Taiwan)
Product: JHL1101 (biosimilar version of rituximab)
Action
mechanism: biosimilar/monoclonal antibody.
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country: UK
Trial details:
Latest
news: On February 14, 2016, JHL Biotech announced it has received authorization from the United Kingdom\'s Medicines and Healthcare Products Regulatory Agency (MHRA) to begin clinical trial for JHL1101, a rituximab biosimilar developed and manufactured by its Taiwanese subsidiary to treat rheumatoid arthritis. JHL is the first company from the Greater China region to receive European approval for clinical trial of a monoclonal antibody biosimilar. The randomized, double-blind, multinational Phase I trial will establish similarity of JHL1101 with its reference product, Roche\'s MabThera®/Rituxan®. JHL seeks to demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity to MabThera as well as the safety and efficacy of JH1101. Approximately 150 patients with severe rheumatoid arthritis will participate in locations throughout Europe. Enrollment of patients into the study is expected to begin in 2016.
