Boehringer continues with rituximab biosimilar

September 21, 2012 2:56 PM

Although Humira (adalimumab) biosimilar was the first product which Boehringer Ingelheim started Phase I trials, now the company is about to start a study for their version rituximab according to ClinicalTrials.gov database. 

As announced earlier, the company entered into biosimilars area and made collaborations already aiming to launch monoclonal antibody biosimilars in the upcoming years. The Phase I study of adalimumab was the primary result of the development programme of Boehringer and now, their rituximab biosimilar is entering into Phase III.

The trial will study Boehringer Ingelheim’s biosimilar (BI 695500) compared to Roche/Genentech’s cancer and rheumatoid arthritis (RA) treatment Rituxan (rituximab), also known as Mabthera. The trial will be conducted in RA patients and the primary objectives of the trial are:

– to show PK similarity of BI 695500 to
– to establish statistical equivalence of efficacy of BI 695500 and rituximab, in patients with moderately to severely active RA, based on the change in DAS28 score measured at 24 weeks compared to baseline and the ACR20 response rate at Week 24.

The recruitment of the study did not start yet but the estimated primary completion date is April 2015.

 

Source: ClinicalTrials.gov

 

 

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