GlobalData conducted an analysis of all biosimilar trials initiated between 2007 and 2016 displays a year-on-year increase in the total number of trials from 9 trials in 2007 to 103 trials in 2016, a growth of 1144%.

However, as seen from Figure 1, there was a slight decrease in total number of trials from 2012 to 2013 (63 to 54), a drop of 15%. In spite of this, as the last 3 years, (2014, 2015 and 2016), display an increasing year-on-year trend; GlobalData suspects it’s safe to estimate that the initiation of biosimilar trials will continue to grow.

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Figure 1- initiated biosimilar clinical trials by phase 2007-2016

Biosimilar trials

Source: GlobalData, Pharma Intelligence Center, Clinical Trials Database [Accessed March13, 2017]

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Further, our analysis showed that there was a dominance of both Phase I and Phase III trials being initiated across all years. Both phases had on average a yearly 36.5% distribution of all biosimilar trials initiated within this ten-year period. In addition, these phases also saw an average rise of 42% from 2007 to 2016.

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The largest period of increase for Phase I trials took place from 2011 with 12 trials to 2012 with 20 trials; additionally Phase III trials saw their highest spike within this same period from 15 trials in 2011 to 30 trials in 2012.  Despite this, both phases went on to reach their peak in 2016, with 34 trials and 51 trials initiated respectively.

In comparison, Phase II and Phase IV trials had an average contribution of all trials with 13% and 14% trials respectively. GlobalData believes this could possibly be due to the risks tied to these specific phases.

Phase I trials are often exploratory in nature with a proof-of-concept perspective to prove a logical rational behind the mechanisms of the drug and as such carries a higher level of failure which effectively acts as a stopping mechanism to the number of drugs progressing to Phase II stage of development. Similarly, the risks for Phase IV trials are also tied to the previous phase, Phase III; should a prospective drug fail to the reach the specific endpoints of the Phase III trial, or prove to be too toxic, it will not progress to Phase IV, resulting in low levels of trials being initiated in this phase.