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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.
Shares Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Regulatory divergence between regions, Prices and value, Trastuzumab.
Shares Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Prices and value, Trastuzumab, Monoclonal antibodies.
Shares Trastuzumab, Nivolumab, Monoclonal antibodies, Pembrolizumab.
Shares Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Prices and value, Nivolumab, Pembrolizumab.
Shares Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Prices and value, Trastuzumab.
Shares Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation, Prices and value, Nivolumab, Pembrolizumab.
Shares Prices and value, Nivolumab, Pembrolizumab.
Shares Prices and value, Trastuzumab, Pembrolizumab.