The US drugs regulator is preparing to accelerate approvals for cheaper generic versions of complex biological medicines, threatening to jeopardise revenue for some of the industry’s most profitable products.
The US Food and Drug Administration is expected to take measures on Wednesday that include reducing the number of certain human clinical studies and cutting costs of medicines engineered with living cells.
The changes would come despite fierce lobbying by the industry’s top representatives in Washington, who have spent millions of dollars to derail less-expensive biological options.
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