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.

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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 Action Plan, aiming to boost the efficiency of development and approval processes of biosimilar and interchangeable drug products. Now, these recent actions represent further steps taken by the FDA to accomplish all proposals set out in the plan.

Stephen Hahn, FDA Commissioner, commented: “Biologic drugs are often complex therapies that can be used to treat some of the most serious illnesses, including autoimmune diseases, rare genetic disorders and diabetes. Life-sustaining insulin products are biologics, but to date, there has been limited competition in the marketplace, resulting in fewer choices and higher prices for patients.”

Under the transition and new pathways, from March 2020 onward, biologic drug applications approved under the Federal Food, Drug and Cosmetic Act will be deemed to have been licensed under the Public Health Service Act as well – including applications for insulins and other biologics.

This will allow for submission of applications for products that are outlined as biosimilar, or interchangeable with, transitioned products, which could allow for greater biosimilar and interchangeable product competition with insulin products.

The newly published final rule and patient and healthcare provider information represent steps taken by the FDA to ensure as smooth regulatory transition as possible. The rule expands the FDA’s definition of the term ‘biological product’ to incorporate changes made by the Biologics Price Competition and Innovation Act and the Further Consolidated Appropriations Act.

The publishing of this rule is intended to balance innovation and competition, to expedite the development, approval and marketing of biosimilar and interchangeable products. This will, in turn, generate greater competition within the market, which has been frequently demonstrated the most effective means of lowering drug costs when there is high drug demand.

Hahn stated: “Opening these products to increased competition is expected to bring down prices and help patients have access to more choices for these life-saving drugs.”

Two ‘frequently asked questions’ documents have also been released by the FDA. These documents – one for patients and one for healthcare providers – seek to provide clarity on what the transition should mean to these stakeholders respectively and reassure individuals that current drug prescribing and dispensing practices should not be affected.



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Ilana Landau

Editor, Future Science Group

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