FDA Reiterates Decision on Suffixes in Biosimilar Naming

A Federal Register notice from FDA addressed comments on the guidance on Proprietary Naming of Biological Products and the agency’s decision to require applicants to submit up to ten proposed, four-letter suffixes for biological products licensed under the Public Health Service (PHS) Act.

In the notice, FDA reiterated its earlier decision to require applicants to “propose a suffix of four lowercase letters for use as the distinguishing identifier included in the proper name designated by FDA at the time of licensure for biological products under the PHS Act.”

Responses to FDA’s guidance, which was initially released in August 2015, indicated that applicants were concerned about the time burden that may encompass coming up with, and providing analysis for, the proposed suffixes. Many respondents commented that FDA’s estimate of two hours per suffix (six hours for three suffixes and analysis) was considerably low. One commenter indicated it would exceed 720 hours per suffix to complete an analysis and submission, totaling 2160 hours. FDA said that while it found this estimate “rather high” it revised its estimate to account for “burden associated with creating and submitting up to 10 proposed suffixes for designation.”

In addition to the time consideration, FDA also mentioned commentary on suffix meaning. Several respondents indicated the importance of selecting a suffix that would help improve pharmacovigilance, enhance safety, and effectively identify a biological product. By comparison, others voiced support for a random suffix, or no suffix at all. FDA did not indicate its preference, and it is still unclear how biosimilar makers should select suffixes.

This lack of clarity triggered responses from organizations including the Biosimilars Forum, which admitted to finding the guidance’s current language confusing. The Biosimilars Forum also indicated that it did not support the suggestion of a random four-letter suffix. Instead, the Forum suggested the implementation of a suffix that is “unique to the original product license holder, and will be affixed to all biological products developed by that license holder.” The Forum also commented on the potential need to change biosimilar labeling information throughout a products lifecycle, specifically mentioning pregnancy and lactation requirements. The Forum indicates that it may not be feasible for biosimilars to adhere to the pregnancy and lactation final labeling rule, since the biosimilar maker does not have access to reference product data.

does not have access to reference product data.

Featured Posts
Recent Posts
Archive
Search By Tags

About Pharmanaming.com and GNN

The Global Naming Network (GNN), headquartered in Geneva, is the world's largest network of independent naming and brand identity agencies.

 

With around 240 cooperating naming and branding specialists in 16  countries, from Beijing to New York and from Seoul to Paris, GNN works for clients ranging from large multinationals to small startups all over the world.

Pharmaceutical projects are coordinated from the GNN office in Amsterdam by the pharma naming specialists of Globrands.

The www.pharmanaming.com website is dedicated to our expertise and work for the health & pharma industry.

 

Please contact us for more information.

20

offices in 16 countries

240

creatives, strategists & consultants

GNN offices

China                     South Korea

France                   Italy
Germany               Japan

Netherlands          UK

India                      Singapore

Spain                     Canada

Switzerland          Russia

USA                       Dubai

5000

projects successfully executed

Pages

home                           name to brand

health & pharma        people

regulatory                   test & submit

India                             FDA

work                             blog

clients                          contact

20000

linguistic professionals worldwide

Globrands the name behind the brands

© 2020 by Globrands consultancy group

Herengracht 122, 1015 BT Amsterdam, the Netherlands

call +31206238555 or mail to pharma@globrands.com  

 

  • White LinkedIn Icon