Navigation Links
ASBM Statement on Final Guidance for Industry Nonproprietary Naming of Biological Products

ARLINGTON, Va., Jan. 13, 2017 /PRNewswire/ -- The Alliance for Safe Biologic Medicines (ASBM) today issued the following statement in response to FDA final guidance on biologic naming:

We commend the FDA for its continued leadership in emphasizing the importance of distinct naming for all biologics, including biosimilars. Our members are keenly aware of the benefits biosimilars will bring to patients, including new treatment options and reduced costs.  

Yet the portion of the Guidance dealing with suffix design remains at odds with the preferences of the physicians who prescribe them and the pharmacists who dispense them, as revealed in two 2015 surveys: The Guidance specifies the distinguishing four-letter suffix be 'devoid of meaning'.

Yet when 400 U.S. biologic prescribers were asked their preference between manufacturer-based suffix such as "sndz" used in Zarxio (filgrastim-sndz), where "sndz" reflects the manufacturer, Sandoz) and random suffixes such as "bflm" (the proposed replacement of  "-sndz"), 60% of prescribers preferred the manufacturer-based format. (9% preferred random, and 32% had no opinion.) Among the 401 pharmacists surveyed, this preference for meaningful, memorable suffixes was even stronger: 77% preferred the manufacturer-based suffix, 15% the random suffix, and 8% had no opinion.

Both groups of providers responded that manufacturer-derived suffixes were easier to recognize and remember, easier to reorder, and that they held manufacturers accountable for their products.

It remains ASBM's position that incorporating a suffix based on the name of the initial manufacturer or marketing authorization holder at the time of approval would promote the most meaningful, memorable, intuitive, and informative method of distinguishing similar biologic products from their reference products and one another. Further, it would better promote accountability by efficiently associating the product with the legal entity ultimately responsible for its production, safety, quality, and efficacy.

Unlike generic versions of chemical drugs, biosimilars are not exact duplicates of their reference products and these differences can result in unexpected effects including reduced efficacy or unwanted immune responses. Therefore, clear product identification of all biologics, including biosimilars, is critical for healthcare providers, patients, and regulators to avoid inadvertent substitution, and to accurately attribute any adverse events to the correct product.

The physicians surveyed support the FDA's issuance of distinct names for all biologics, including biosimilars by a factor of 6-to-1. (66% support, 11% oppose, 23% expressed no opinion).  Similarly, an October 2015 survey of 401 U.S. pharmacists showed 68% supported the FDA issuing distinct names for all biologics, including biosimilars.

About ASBM
Formed in 2010, ASBM is an organization of patients, physicians, pharmacists, researchers, manufacturers of both innovative and biosimilar medicines, and others who are working together to ensure patient safety remains at the forefront of the biosimilars policy discussion.

For more information, please contact:
Michael Reilly
Executive Director
Alliance for Safe Biologic Medicines
Phone: 202-222-8326

ASBM Steering Committee Members:
Alliance for Patient Access
American Academy of Dermatology
American Autoimmune Related Diseases Association (AARDA)
Association of Clinical Research Organizations
Colon Cancer Alliance
Global Colon Cancer Association
Global Healthy Living Foundation
Health HIV
Hepatitis Foundation International
International Cancer Advocacy Network
Kidney Cancer Association
National Psoriasis Foundation


To view the original version on PR Newswire, visit:

SOURCE Alliance for Safe Biologic Medicines
Copyright©2017 PR Newswire.
All rights reserved

Related biology technology :

1. Vestiage Announces Filing of Disclosure Statement with Exchange
2. Regado Biosciences, Inc. Files Registration Statement for Proposed Initial Public Offering
3. CLD Integrates Tin CAN API with its eLearning Solutions and Launches its Excelerometer Tracking Statement Dashboard
4. Cellular Dynamics International Files Registration Statement for Proposed Initial Public Offering
5. Royalty Pharma Statement Regarding Elan Law Suits
6. Vermillions OVA1 Receives New Statement by Society of Gynecologic Oncology
7. Intrexon Announces Filing of Registration Statement For Proposed Initial Public Offering
8. Life Technologies Announces Filing of Definitive Proxy Statement
9. Panetta Statement on Passing of Duane Roth
10. Perrigo Files Registration Statement On Form S-4 In Connection With Proposed Acquisition Of Elan
11. PharmAthene Files Registration Statement On Form S-4 With The Securities and Exchange Commission
Post Your Comments:
(Date:5/14/2019)... ... 2019 , ... Gateway Genomics , a leading developer of prenatal and ... 5,000 square feet. , “This past year has seen exponential growth for the ... Chris Jacob. “The SneakPeek At-Home test, which is mailed directly to our customers who ...
(Date:5/4/2019)... ... May 03, 2019 , ... ... President of the Dakila Pesquisas Association, the scientist and ufologist Urandir Fernandes de ... Brasília (DF). Urandir detailed the results of some research carried out by the ...
(Date:5/2/2019)... ... April 30, 2019 , ... The centuries old practice of ... breweries to local craft breweries, and even home brewing clubs scattered across the nation. ... biological processes, that when mastered can produce a superb product. Students at South ...
(Date:5/2/2019)... , ... May 02, 2019 , ... ... clinic in the greater Boston area. Gone are the days of painful hair ... iX Robotic Hair Restoration System is the only robotic intelligent solution to offer ...
Breaking Biology Technology:
(Date:6/13/2019)... ... June 13, 2019 , ... Global Clinical and Ancillary Supply ... clinical and ancillary supply chain management needs of large- and middle-market pharmaceutical, biotechnology, ... announced it will sponsor a summer education program offered by the Young Men ...
(Date:6/6/2019)... ... 05, 2019 , ... Ziegler, a specialty investment bank, is ... Laboratories (PBM) on its recent acquisition by PathGroup. , Headquartered in Lewisville ... more than one dozen hospitals and surgery centers in the Dallas-Fort Worth and ...
(Date:6/4/2019)... , ... June 04, 2019 , ... Lajollacooks4u is delighted ... recipients. The recognition, which honors hospitality excellence, is given only to businesses that have ... Excellence for five consecutive years. , To qualify for the Certificate of ...
Breaking Biology News(10 mins):