Senators urge changes to FDA guidance on insulin

5 March 2019

Senators in the US Congress have written to the US Food and Drug Administration seeking changes to official guidance, with the aim of expediting the release of new biosimilar insulin products.

The letter comes shortly after Eli Lilly (NYSE: LLY) announced it will introduce a steeply discounted version of its own Humalog (insulin lispro) in the USA.

The FDA is due to begin work in March 2020 transitioning certain approved products to be classed as biologics. This will include insulin and human growth hormone.

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