FDA issues new rule on definition of term ‘biological product’

INICIO/Directrices | Posted 06/03/2020 post-comment0 Post your comment

The US Food and Drug Administration (FDA) announced on 20 February 2020 that it had issued a final rule on the definition of the term ‘biological product’.


In the final rule, which was published in the Federal Register on 21 February 2020, FDA amends its regulation that defines what is a ‘biological product’ to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020 (FCA Act), and to provide its interpretation of the statutory term ‘protein’.

The rule is one of the last steps in finally enabling the transition of biologicals that are currently approved under the Food, Drug, and Cosmetic Act (FD&C Act) of the Public Health Service Act [1]. This will enable biologicals, including insulin products, insulin mix products and insulin analogue products (insulin products), to be approved via the abbreviated biosimilars pathway.

Definition of the Term ‘Biological Product’
Date: 21 February 2020

Under this final rule, the term protein means any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. This final rule is intended to clarify the statutory framework under which such products are regulated.

The rule becomes effective on 23 March 2020 and will mean that around 100 products approved under new drug applications (NDAs) will transition to biological license applications (BLAs).

FDA Commissioner Dr Stephen M Hahn said that ‘this transition will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition in the marketplace’. This, he added, ‘is expected to bring down prices and help patients have access to more choices for these life-saving drugs’. Finally, he said that the agency would ‘continue to communicate relevant information, including the resources we’ve issued today, to make the transition from one statutory framework to another as seamless as possible’.

In addition to the final rule, FDA also published frequently asked questions documents for patients and healthcare providers explaining more about the transition.

Related article
FDA issues draft guidance for insulin biosimilars

1. GaBI Online - Generics and Biosimilars Initiative. Comments on FDA’s plans to transition insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 6]. Available from: www.gabionline.net/Guidelines/Comments-on-FDA-s-plans-to-transition-insulin-products

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Source: Federal Register, US FDA

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