FDA is making biological products more easily distinguishable

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submit no more than three four-letters randomly selected suffixes and in the order of the applicant’s preference in a draft guidance document.
In 2016, a guidance document calling for ten randomly selected suffixes was withdrawn two weeks after being published.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.

Reference:  Nonproprietary Naming of Biological Products. FDA Guidance for Industry. (January 2017)

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.

Lorem Ipsum: when, and when not to use it

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Where can I get some?

There are many variations of passages of Lorem Ipsum available, but the majority have suffered alteration in some form, by injected humour, or randomised words which don’t look even slightly believable. If you are going to use a passage of Lorem Ipsum, you need to be sure there isn’t anything embarrassing hidden in the middle of text.

All the Lorem Ipsum generators on the Internet tend to repeat predefined chunks as necessary, making this the first true generator on the Internet. It uses a dictionary of over 200 Latin words, combined with a handful of model sentence structures, to generate Lorem Ipsum which looks reasonable. The generated Lorem Ipsum is therefore always free from repetition, injected humour, or non-characteristic words etc.

Where does it come from?

Contrary to popular belief, Lorem Ipsum is not simply random text. It has roots in a piece of classical Latin literature from 45 BC, making it over 2000 years old. Richard McClintock, a Latin professor at Hampden-Sydney College in Virginia, looked up one of the more obscure Latin words, consectetur, from a Lorem Ipsum passage, and going through the cites of the word in classical literature, discovered the undoubtable source.

Lorem Ipsum comes from sections 1.10.32 and 1.10.33 of “de Finibus Bonorum et Malorum” (The Extremes of Good and Evil) by Cicero, written in 45 BC. This book is a treatise on the theory of ethics, very popular during the Renaissance. The first line of Lorem Ipsum, “Lorem ipsum dolor sit amet..”, comes from a line in section 1.10.32.

Why do we use it?

It is a long established fact that a reader will be distracted by the readable content of a page when looking at its layout. The point of using Lorem Ipsum is that it has a more-or-less normal distribution of letters, as opposed to using ‘Content here, content here’, making it look like readable English.

Many desktop publishing packages and web page editors now use Lorem Ipsum as their default model text, and a search for ‘lorem ipsum’ will uncover many web sites still in their infancy. Various versions have evolved over the years, sometimes by accident, sometimes on purpose (injected humour and the like).