FDA takes steps to increase market access of insulin and biologic products

The US FDA has published a final rule, alongside additional resources, aiming to ensure the smooth regulatory transition of insulin and biologic products, ultimately hoping to lower therapeutic prices and boost market access. Insulin products are used daily by millions of individuals with diabetes in the USA. Now, the US FDA has published a final rule — amending its definition of the term ‘biological product’ — alongside additional resources, aiming to expedite the smooth regulatory transition of insulin and biologic products to market, potentially leading to reduced drug costs and increased market access. In 2018, the FDA issued a Biologics...