Israeli generics giant Teva Pharmaceutical Industries (Teva) has suspended its phase III trial of its biosimilar version (TL011) of Roche’s Rituxan/MabThera (rituximab).
The trial was a multicentre, double-blind, randomised, active controlled, parallel-group study. Teva planned to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate. The trial was being carried out in Europe and started recruiting patients, aged 18 to 80 years, in May 2012. According to Israeli newspaper Haaretz the company is ‘considering how best to meet the requirements’ from EMA and FDA.
Roche’s blockbuster cancer and rheumatoid arthritis treatment ranks among the top three biological drugs worldwide and sold US$6.6 billion worth of drugs worldwide in 2011. Rituxan’s patent protection will expire in Europe in 2013 and in 2018 in the US.
With patent expiry expected soon, many of Teva’s rivals are already forging ahead with clinical trials.
Sandoz (Novartis’s generics unit) is currently conducting a phase I/II clinical trial for its biosimilar (GP2013) in patients with rheumatoid arthritis [1] and a phase III trial in patients with advanced stage follicular lymphoma.
Pharma giant Pfizer is conducting a phase I/II clinical trial for its biosimilar (PF-05280586) in patients with rheumatoid arthritis [2] and a phase I trial for patients with CD20 positive Non-Hodgkin’s Lymphoma.
Merck is conducting a phase I trial for its biosimilar (MK-8808) in patients with rheumatoid arthritis. While South Korean Celltrion, in a joint venture with Hospira, is testing its biosimilar (CT-P10) in a phase I trial for rheumatoid arthritis patients and in another phase I trial for patients with lymphoma.
Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) also announced in August 2012 that the biologicals specialist was starting a phase III trial for a biosimilar version of rituximab (BI 695500) in patients with moderately to severely active rheumatoid arthritis [3].
In 2011, US-based biologicals companies Spectrum Pharmaceuticals and Viropro signed a pact to develop a biosimilar version of rituximab ahead of its US patent expiry in 2018, while plant-made pharmaceuticals specialist iBio announced in October 2011 that it had successfully produced a rituximab biosimilar in non-transgenic green plants [4].
Finally, contract research organisation Quintiles announced in February 2011 a deal with electronics giant Samsung to provide biologicals manufacturing and biosimilars development. Their biosimilar version of rituximab is expected to be in production by 2016 [5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Sandoz announces biosimilar rituximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 12]. Available from: www.gabionline.net/Biosimilars/News/Sandoz-announces-biosimilar-rituximab
2. GaBI Online - Generics and Biosimilars Initiative. Also noted on biosimilars: 11 May 2012 Posted 11/05/2012. Pfizer starts phase I/II biosimilar rituximab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 12]. Available from: www.gabionline.net/Biosimilars/General/Also-noted-on-biosimilars-11-May-2012
3. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim starts biosimilar rituximab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 12]. Available from: www.gabionline.net/Biosimilars/Research/Boehringer-Ingelheim-starts-biosimilar-rituximab-trial
4. GaBI Online - Generics and Biosimilars Initiative. Rituximab biosimilar successfully produced in plants [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 12]. Available from: www.gabionline.net/Biosimilars/News/Rituximab-biosimilar-successfully-produced-in-plants
5. GaBI Online - Generics and Biosimilars Initiative. Samsung to enter biosimilars market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 12]. Available from: www.gabionline.net/Biosimilars/News/Samsung-to-enter-biosimilars-market
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Source: ClinicalTrials.gov, Haaretz, WHO
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