UK To Diverge On Biosimilar Data Requirements
But EU Off-Patent Industry Prefers Global Approach
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.
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The UK is putting itself in a position to play a leading role in global biosimilars regulation, thanks to a proposed new registration pathway that will not require comparative efficacy data, delegates to a Westminster Health Forum online conference heard.
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.
The International Generic and Biosimilar medicines Association 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 health care professionals.