Biosimilars could be launching a lot earlier in the UK than the EU thanks to new guidance, improved HCP education and lenient Bolar exemption legislation. More on each of these below.
1.Confirmatory efficacy trials not required
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has now released new guidance which details that for most cases, the UK will not require a confirmatory efficacy trial, unlike the EU.
To drive the switch to biosimilar use, and position the UK as a desirable launch market, there’s increased focus on educating and engaging professionals on the topic. Uptake of biosimilars is already increasing, particularly in Oncology.
The Bolar exemption allows manufactures to conduct necessary studies and trials without the risk of patent infringement. Though available throughout the EU, its implementation varies between countries. The UK legislation offers the broadest form of exemption.
Wondering how to navigate the new landscape?
Remap Consulting have significant experience working with pharmaceutical and biotech companies in helping them navigate global market access.
If you have any questions or would like to hear how we can support you in getting your product to market email Paul and Graham, managing directors, today at: email@example.com .