Currently, the production of biosimilars is hindered by an extremely time-consuming, costly and complex clinical development process, largely due to the default inclusion of Phase III clinical trials. These typically involve several hundred patients, take two to four years to complete and cost between £20m-£150m ($27m-$205m).

The experience and evidence obtained after more than 100 approved biosimilars in the EU presents a strong argument to shift away from conducting Phase III trials by default. We therefore welcome the EMA’s moves towards a more streamlined development process. What we really need now is finalized updated guidance and a first decision to implement this updated regulatory thinking and approve a complex biosimilar application without a Phase III trial. Until then, biosimilar manufacturers will remain locked in a state of caution, and patient access to affordable high quality biosimilars will remain muted.

Less dependence on Phase III trials would have a positive impact on the overall industry landscape, removing a significant barrier to entry for biosimilars developers. This would open up the market to increased competition, which would drive down prices even further and increase patient access to essential medicines.

It would also help to tackle the ‘biosimilars void’, with just 29% of molecules having a biosimilar in development out of all the biological medicines anticipated to lose exclusivity in Europe by 2030. As a biosimilar currently costs £100m-£150m and takes five to seven years to develop, the reality is that it is just not economically feasible for companies to pursue many of the more niche biosimilars.

This is why streamlining biosimilars is so important: removing the need to have Phase III clinical trials – where scientifically justified – will help to remove an extremely costly and time-consuming part of the development process. The barriers to entry would be significantly lowered, enabling companies to more sustainably fill this ‘biosimilars void’.

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