To understand the potential impact of the new MHRA guidance for biosimilar licensing in the UK and other key markets, in terms of accelerating biosimilar development, time to market, prescribing limits (e.g. automatic substitution) and, patient access to biologics.
We reviewed the MHRA guidance on biosimilar licensing, alongside that from the FDA/EMA, and country-specific guidance on biosimilar use. We also analysed FDA/EMA approvals for biosimilars approved without confirmatory efficacy trials. Finally, a virtual iAdBoard was organised with payers/KOLs from France, the UK and US to capture different perceptions on the new policy and downstream impacts on biosimilar access.
The MHRA has discontinued the requirement for biosimilars to undergo confirmatory efficacy trials as a licensing condition. Although the new policy was celebrated by the biosimilar industry, one must note the FDA and EMA do not explicitly state a Phase 3 trial requirement for biosimilar approval, and to date, two pegfilgrastim biosimilars have been approved without a Phase 3 trial (Udenyca, Nyvepria), given their robust chemical characterization and Phase 1 trials’ Results: Additionally, the new MHRA guidance contemplates exceptions where comparative trials are required, leaving uncertainty around for how many biosimilars, particularly monoclonal antibodies, chemical characterization plus PK/PD trials will suffice. The virtual iAdboard revealed payer differences in opinion regarding impacts on biosimilar development timelines (vs agreement on economic viability), and in future policies encouraging biosimilar uptake, with EU payers more receptive to the change than US counterparts, but concerned with backlash from HCPs.
If the FDA/EMA endorse the MHRA decision, in the future, a strong CMC/Phase 1 package could replace Phase 3 studies for biosimilar licensing. However, it is yet unclear whether this abbreviated data package will result in faster times to market or if it will have negative impacts on prescribing freedom and patient access to biosimilars.
© 2021 Published by Elsevier Inc.