Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) has reportedly halted clinical development for its biosimilar version (BI 695500) of Roche’s blockbuster leukaemia treatment Rituxan/MabThera (rituximab).
Rituximab is approved in the EU and the US to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia and rheumatoid arthritis, as well as to treat diffuse large B-cell lymphoma in the EU.
According to the EU clinical trials register, Boehringer Ingelheim has ‘prematurely ended’ two phase III trials in lymphoma patients and a phase III trial in rheumatoid arthritis patients, as well as an open-label extension trial in rheumatoid arthritis patients.
Boehringer Ingelheim created a dedicated division for the development and commercialization of biosimilars back in September 2011 [1] and started phase III trials for biosimilar rituximab in 2012 [2].
Similar decisions were made by Teva Pharmaceutical Industries (Teva) and South Korean electronics giant Samsung. Israeli generics giant Teva suspended the phase III trial of its biosimilar rituximab (TL011) in 2012, saying that it was ‘considering how best to meet the requirements’ from the US Food and Drug Administration and the European Medicines Agency [3]. Samsung suspended clinical development for its biosimilar rituximab (SAIT101) in 2013, with speculation that the company was being forced to redo tests from scratch due to changes in safety requirements in Europe and the US [4].
The news comes somewhat as a surprise considering that the phase III trials for Boehringer Ingelheim’s BI 695500 were expected to be completed in August 2015 [5].
The stakes are high and any delays will cost more for biosimilars companies and delay access to cheaper biosimilars. The patents on MabThera/Rituxan already expired in Europe in February 2013 and expire in the US in September 2016 [6].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim joins other Big Pharma going into biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 30]. Available from: www.gabionline.net/Biosimilars/News/Boehringer-Ingelheim-joins-other-Big-Pharma-going-into-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim starts biosimilar rituximab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 30]. Available from: www.gabionline.net/Biosimilars/Research/Boehringer-Ingelheim-starts-biosimilar-rituximab-trial
3. GaBI Online - Generics and Biosimilars Initiative. Teva halts phase III biosimilar rituximab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 30]. Available from: www.gabionline.net/Biosimilars/News/Teva-halts-phase-III-biosimilar-rituximab-trial
4. GaBI Online - Generics and Biosimilars Initiative. Samsung halts biosimilar rituximab development [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 30]. Available from: www.gabionline.net/Biosimilars/News/Samsung-halts-biosimilar-rituximab-development
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of rituximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 30]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-rituximab
6. GaBI Online - Generics and Biosimilars Initiative. Biological patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 30].
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Source: EU Clinical Trials Register
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