美国食品和药物管理局更新生物类似药规则,以降低成本,加快获取低价生物药物. FDA updates biosimilar rules to cut costs and speed access to lower-priced biologic drugs.

美国食品和药物管理局发布了指导草案,旨在通过减少不必要的药物动力学测试和允许使用外国临床数据来简化生物类似药的开发,从而可能将成本降低高达50%,并加速获得癌症和自身免疫性疾病等低价生物治疗方法. The FDA released draft guidance to streamline biosimilar development by reducing unnecessary pharmacokinetic testing and allowing use of foreign clinical data, potentially cutting costs by up to 50% and speeding access to lower-priced biologic treatments for conditions like cancer and autoimmune diseases. 该机构正在撤回其2015年指南,这反映了自2009年以来审查82个核准的生物类似物的最新科学经验。 The agency is withdrawing its 2015 guidance, reflecting updated scientific experience from reviewing 82 approved biosimilars since 2009.