UK Lays Out Reduced Data Pathway For Biosimilars
Chance For Post-Brexit Country To Be First Launch Market
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.
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The IGBA wants to take discussions around streamlining biosimilar development to “the next level”, the association tells Generics Bulletin.
The IGBA has called for a “streamlined” global biosimilar development and registration process, with a new policy paper highlighting the limited value of comparative efficacy clinical data at the same time as it urges renewed efforts on educating healthcare professionals.
The UK regulator wants to be a “catalyst for change” in reducing regulatory burdens, saying that better regulation based on science is in everyone’s interest.