Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) is starting a Phase III trial for a biosimilar version of rituximab.
The biopharmaceutical specialist announced on 26 September 2011 that it would create a dedicated division for the development and commercialization of biosimilars, and it seems this is the first product resulting from that effort.
The Phase III trial will study the efficacy, safety and pharmacokinetics of Boehringer Ingelheim’s biosimilar (BI 695500) compared to Roche’s blockbuster cancer and arthritis treatment Rituxan (rituximab), also known as MabThera. The trial is a randomized, double-blind, parallel arm, multiple dose, active comparator trial and will consist of five groups of patients, two of which will receive the biosimilar and three of which will receive Rituxan. All patients will receive two IV infusions of the drugs separated by a two-week wash-out period.
The primary objectives of the trial are to show the pharmacokinetic similarity and equivalence of efficacy of Boehringer Ingelheim’s biosimilar (BI 695500) to Rituxan, in patients with moderately to severely active rheumatoid arthritis. The evaluation of the drugs will be based on the change in Disease Activity Score 28 (DAS28) score measured at 24 weeks compared to baseline and the American College of Rheumatology 20% (ACR20) response rate at Week 24.
The safety and efficacy study includes adults aged 18 to 80 years, started in September 2012 and is expected to be completed in April 2015.
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Source: www.gabionline.net
