Additional Relevant Details The randomized, double-blind, multinational Phase I trial will establish similarity of JHL1101 with its reference product, Roche’s MabThera. 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. As a biosimilar with the same delivery mechanism and dosing as MabThera, JHL1101 is exempt from Phase II trial requirements and is eligible to undergo Phase III trial when the Phase I trial is concluded and similarity with the reference product is further validated. MabThera is the brand name for rituximab in most of the world, except for the United States, Canada, and Japan where it is administered under the name Rituxan. Rituximab is one of the most commonly used monoclonal antibody treatments for rheumatoid arthritis.The randomized, double-blind, multinational Phase I trial will establish similarity of JHL1101 with its reference product, Roche’s MabThera. 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. As a biosimilar with the same delivery mechanism and dosing as MabThera, JHL1101 is exempt from Phase II trial requirements and is eligible to undergo Phase III trial when the Phase I trial is concluded and similarity with the reference product is further validated. MabThera is the brand name for rituximab in most of the world, except for the United States, Canada, and Japan where it is administered under the name Rituxan. Rituximab is one of the most commonly used monoclonal antibody treatments for rheumatoid arthritis.