Clinical programmes for oncology biosimilars

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Inscribirse
eng / esp

Clinical programmes for oncology biosimilars

INICIO/Informes | Posted 28/08/2015 0 Post your comment

Biosimilars for oncology drugs are currently under development. These include biosimilars of blockbusters such as Roche’s Avastin (bevacizumab), MabThera/Rituxan (rituximab) and Herceptin (trastuzumab).

The drugs are used to treat various cancers, including breast, colorectal, leukaemia, lung, non-Hodgkin lymphoma and ovarian cancers, as well as rheumatoid arthritis.

Biosimilars makers’ strategies for oncology biosimilars appear to be more challenging than for anti-tumour necrosis factor (TNF) biosimilars. Problems being encountered by biosimilars makers include recruiting difficulties and early phase III programmes running into challenges. This may mean that oncology biosimilars appear on the market 2–3 years later than anti-TNF biosimilars. Another challenge is that originator companies may also be able to shift a segment of the market to follow-on therapies [1].

Pivotal trials for oncology biosimilars being carried out typically include just one study of the response rate with some progression-free survival (PFS) data. The trials take 24–48 months and are tougher trials to recruit and execute than anti-TNF trials [2].

In the following series of three articles the pivotal clinical trials being carried out for bevacizumab, rituximab and trastuzumab biosimilars are presented.

Pivotal clinical trials for rituximab biosimilars

Pivotal clinical trials for bevacizumab biosimilars

References
1. Gal R. Biosimilars: at the inflection point. 13th EGA-European Biosimilars Group Conference; 23–24 April 2015; London, UK.
2. GaBI Online - Generics and Biosimilars Initiative. Clinical programmes for anti-TNF biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 28]. Available from: http://www.gabionline.net/Reports/Clinical-programmes-for-anti-TNF-biosimilars

Permission granted to reproduce for personal and non-commercial 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.