Boehringer Ingelheim starts biosimilar rituximab trial

Biosimilars/Research | Posted 21/09/2012 post-comment0 Post your comment

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 [1], 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.

Related article

Boehringer Ingelheim acquires Amgen biotech site


1.  GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim joins other Big Pharma going into biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Sep 21]. Available from:

Permission granted to reproduce for personal and educational use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: Boehringer Ingelheim,

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010