FDA Urged to Preserve Biosimilar Naming Conventions - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Urged to Preserve Biosimilar Naming Conventions


The Generic Pharmaceutical Association (GPhA) is reporting that 32 organizations, including pharmacies and labor unions, have signed a letter urging FDA to require biologics and biosimilars to have the same International Nonproprietary Name (INN). The practice is already established in Europe and other markets.

“These groups understand that the INN approach to biosimilar naming has proven safe and effective in Europe; it has worked in the United States for chemical drugs and currently approved biologics, therefore it should be the standard for U.S. biosimilars," said Ralph G. Neas, president and CEO of GPhA, in a press release. “The organizations who know the most about healthcare delivery agree: departing from the currently accepted INN system will not benefit patients,” said Neas. “Instead, it will upset the very systems needed to accurately dispense and track medicines, risking increased mistakes and provider confusion.”

The letter follows concerns raised by the National Council of Prescription Drug Programs (NCPDP). In a letter to FDA, NCPDP cited operational problems with the implementation of a system other than the current INN system and stated concerns about what kind of impact that a change in system would have on standard operating procedures.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality

Click here