Approve cancer biosimilars on analytics and pharmacokinetics, no efficacy trials
Copies of biological cancer drugs are still required to run large trials that rarely change the answer. Dropping them would cut years and tens of millions from each biosimilar.
The MHRA has not required comparative efficacy trials for most biosimilars since 2021, the EMA published a 2025 reflection paper proposing to waive them where analytical and pharmacokinetic similarity are shown, and FDA has signalled the same direction. Comparative efficacy trials for oncology monoclonal antibodies (trastuzumab, bevacizumab, rituximab, and soon pembrolizumab and nivolumab as patents expire around 2028) cost tens of millions and have essentially never overturned a positive analytical package. The proposal is a coordinated ICH-level waiver with a shared analytical similarity standard, so a biosimilar programme runs once for all regions.
- Prices and value · New cancer drugs routinely cost over $150,000 a year, often for months of benefit. Systems cannot afford them and patients go bankrupt.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.