FDA changes rules for insulin in hopes of decreasing prescription costs

Insulin has historically been categorized as a small molecule drudge, because when it was first discovered there wasn’t another category. But, if insulin were discovered today, it would be grouped as a “biologic.”  

The FDA believes that being grouped with small molecule drugs made it harder for insulin generics to be approved. To address this concern, the FDA officially recategorized insulin as a biologic on March 23, 2020. By opening up the biosimilar approval pathway for insulins, the FDA hopes that it will now be easier for new insulin brands to come to the market and create price-based competition. 

Will this increase competition and decrease prices? It’s unclear.  Currently, there is little competition in the insulin markets, with there being no more than two suppliers of any specific insulin molecule (for example, Lantus and Basaglar are the only available options in the US for insulin glargine). The JDRF does not think biosimilars are the answer, and actual savings around the world range from 5-70% depending on the nation and the medication. 

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