UK Lays Out Reduced-Data Pathway For Biosimilars
Creates Opportunity For Country To Be First Launch Market, Industry Says
The UK’s MHRA has laid out its plans for a biosimilar licensing pathway that will typically not require comparative efficacy data and will consider approved biosimilars interchangeable with their reference products for all indications. Local industry believes the guideline creates an opportunity for the UK to be the first launch market for biosimilars.
You may also be interested in...
Sandoz CEO Richard Saynor says that advances around biosimilars mean that they can offer a simple and meaningful way to help solve the “paradox” of modern healthcare in providing broader access to the latest and best treatments.
Departing BGMA leader Warwick Smith highlights successes in the UK off-patent industry’s response to the COVID-19 pandemic but offers unambiguous criticism of Brexit in the concluding part of an exclusive interview with Generics Bulletin.
The UK’s implementation of a new national licensing framework for biosimilars has been pushed back from the start of 2021, with the MHRA citing “intense COVID-19 activities” as the cause of an indefinite delay in the consultation process.