FDA Draft Guidance Requiring Distinct Naming for Biosimilars

Biosimilar Naming Policy Will Help Ensure Patient Safety and Transparency

ATLANTA – The American College of Rheumatology (ACR) today praised the Food and Drug Administration (FDA) for issuing draft guidance requiring separate and distinct names for biosimilars and biologic therapies.

The guidance, “Nonproprietary Naming of Biologic Products,” would designate separate and distinct, non-proprietary names for originator biologic products, related biological products, and biosimilar products.

“The ACR commends the FDA’s proposal to require distinctive names for biosimilar drugs and original biologics,” said Douglas White, MD, Chair of the ACR’s Committee on Rheumatologic Care. “Distinctive names will allow for greater transparency in substitution and notification, making it clear to all parties involved – pharmacists, providers and patients – which drug the patient is receiving.”

The ACR previously issued a position statement calling on the FDA to enforce distinct names for biosimilars, and has spoken with FDA officials and submitted comment letters expressing its concerns for patient safety in instances where biosimilars are substituted without proper patient and physician notification.

Rheumatologists prescribe biologics to help patients with arthritis, lupus and other forms of rheumatic disease to manage symptoms, ease pain and avoid long-term disability. Concerns about the complexity of biologics and the potentially life-threatening adverse reactions when biosimilars are substituted without physician and patient notification have led the rheumatology community to call for stricter oversight and more transparency in the notification and substitution process.

“The FDA’s proposal to require distinguishable names for biosimilars will help rheumatologists and other specialists ensure patients continue to receive breakthrough therapies that are both clinically appropriate and effective, without compromising their health or safety,” Dr. White concluded.

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