Regulatory progression, changes at the courts and post-Brexit flexibility contribute to crafting an enticing landscape from which to launch products, making the UK jurisdiction of choice for biosimilars.
Following a consultation late last year, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on 6th May 2021 explaining that in most cases the UK will not require a confirmatory efficacy trial. Approval will instead be based on a more streamlined package of pharmacokinetic studies and physicochemical data.
This change will result in a more efficient and cheaper approval process for biosimilars in the UK compared to Europe and the US, removing the need for costly clinical efficacy trials.
Read the full article on the IAM website.