US needs registry for naming biosimilars, author says

US needs registry for naming biosimilars, author says

June 8, 2012

The industry should collaborate to develop a US Biopharmacopeia Registry of Biopharmaceutical Products to help resolve biosimilar and broader biopharmaceutical nomenclature issues, according to a leading author and publisher.

The industry should collaborate to develop a US Biopharmacopeia Registry of Biopharmaceutical Products to help resolve biosimilar and broader biopharmaceutical nomenclature issues, according to a leading author and publisher.

Ronald A. Rader, president of the Biotechnology Information Institute and author and publisher of BIOPHARMA: Biopharmaceutical Products in the US and European Markets, discussed the controversy and his reasoning for an industry-based and industry-funded registry modeled after the Personal Care Products Council in an article published online in the June issue of BioProcess International.

“No one knows how to portray, classify, identify, or name biopharmaceutical products, including biosimilars,” he wrote. “Biopharmaceutical nomenclature is too important to leave fully in the hands of the FDA and governments, and rightfully the industry should have input or even control of its products’ names.”

According to Rader, FDA has not yet disclosed how it will implement biosimilar approvals. However, the process, which requires the agency to designate established names, is likely to be controversial because of the inherent problems with defining a distinct biopharmaceutical and the multiple traditional methods for selecting established names. 

Established names will be the first descriptor of the products that users will encounter, he said; therefore, the names will profoundly affect healthcare and consumer perceptions of the product (eg, whether the products are generic), which in turn will largely influence their use, branding, and marketing, he wrote.

Rader explained that considerations for naming include:

Fully unique meaningless contrived names with no relationships discernible among biosimilar products.

Unique biosimilar names.

Unique names based on adding commercial descriptors to USANs.

Biosimilar stems such as a manufacturer's name or trade name.

Biosimilar or unique names based on product class such as mechanism of action.

Each method presents different advantages and disadvantages for marketing, prescriptions, product surveillance, and information organization and retrieval, Rader wrote.

Organizations typically involved in nomenclature either seem disinterested or carry conflicts of interest and incentive for private sector involvement is lacking, he added.

So this industry collaborative ideally would be funded by trade associations, companies, and/or FDA. And the collaborative would “propose candidate unique, biosimilar, (bio) generic, and other needed types of names for selective adoption by regulatory agencies, reference works, formularies, media, and other diverse uses and users; and will provide a public registry website relating names for active agents and products.”