UK Lays Out Reduced Data Pathway For Biosimilars
Chance For Post-Brexit Country To Be First Launch Market
Executive Summary
The UK drug regulator, the 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. The local biosimilars industry believes the guideline creates an opportunity for the UK to be the first launch market for its products.