Global Regulatory Gridlock Hinders Biosimilar Savings
A recent study reveals global regulatory inconsistencies in biosimilars, urging convergence to enhance access and savings for patients and health care systems.
An international qualitative study highlighted deep-rooted inconsistencies in international approval pathways, imposing unnecessary development delays and increased expenses on biosimilar medicines.
The fragmented global regulatory landscape prompted an expert panel to issue 16 high-consensus recommendations aimed at fostering global regulatory convergence and speeding up access to these essential cost-saving therapies.
Author's summary: Regulatory inconsistencies hinder biosimilar access.
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