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.

Related articles
Pivotal clinical trials for trastuzumab biosimilars

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

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