FDA is making biological products more easily distinguishable
The US Food and Drug Administration (FDA) recently released the final version of the guidance document about nonproprietary naming of biological products. This long awaited document applies to originator biological products, related biological products and biosimilars previously licensed and newly licensed.
The aim of this new naming convention is to enhance pharmacovigilance and allow healthcare practitioners and patients to easily identify and distinguish the biological products. The high complexity of biological products means that similar biologics may have different immunological impact on patients. FDA hopes to help prevent inadvertent substitution of biological products that were not found to be interchangeable in order to ensure the safe use of biologics.
In 2015, the Agency called for companies to submit no more than three four-letters randomly selected suffixes and in the order of the applicant’s preference in a draft guidance document.
In 2016, a guidance document calling for ten randomly selected suffixes was withdrawn two weeks after being published.
These changes reflect the rapidly evolving approach of the agency to biologics based on comments from pharmaceutical companies and healthcare providers. As more biological products are being approved, the agency is seeking to reduce the risk of medication error and make sure that safe and effective biological products reach patients.
In the final guidance document published this year, FDA announced that up to ten suffixes should be submitted during the IND or at the time of BLA submission. These should be composed of four lowercase letters, ‘devoid of meaning’, and attached to the core name with a hyphen. Out of these four letters, at least three should be distinct. The suffixes can be submitted in the order of the applicant’s preference and should be unique. The agency also recommends to applicants to include any supporting analyses of the proposed suffixes to demonstrate that they meet the required criteria.
Finally, the FDA also went over the retrospective naming of biological product which will, according to the agency, help with medication error, ease manufacturer-specific pharmacovigilance, encourage routine use of these suffixes and finally advance accurate perception of these biological products. Also, applying this naming convention to already-approved products is to prevent misinterpretation that biosimilars are inferior to their reference products.
Nitisha Pyndiah, PhD, is a Consultant where she provides advice for the development of biological, biotechnological, and biosimilar products.
Nitisha provides expertise in the areas of virology, molecular biology, microbiology, immunology, immunogenicity, quality control, GLP and GMP. She prepares and evaluates CMC sections, including FDA meeting documents; and conducts scientific and regulatory gap analyses. She supports technical, strategic, and operational regulatory affairs for recombinant proteins, monoclonal antibodies, and vaccines.