Updated UK guidance on the country’s new biosimilars licensing pathway has been welcomed by the off-patent industry, both locally and internationally. The UK Medicines and Healthcare products Regulatory Agency’s latest guidance – published after a stakeholder consultation – confirms that the MHRA will be pioneering the approach of not typically requiring comparative efficacy data, while approved biosimilars will be considered to be interchangeable with their reference products, albeit without pharmacy-level substitution.
“Although each biosimilar development needs to be evaluated on a case by case basis, it is considered that, in most...
