November 2, 2015
On August 28, 2015, FDA published a draft guidance entitled “Nonproprietary Naming of Biological Products.” If finalized, the draft guidance will establish a naming convention for biosimilars. The document was available for comment until October 27. One comment that FDA received was from the Federal Trade Commission (FTC) which expressed concerns with FDA’s proposed naming convention.
The Agency’s proposed plan states that both branded and biosimilar products will share what they call a “core drug substance” name. Each product will also have a suffix that will be made up of four letters. The suffixes will not be derived from the manufacturers name and will be individualized from product to product (for more details on FDA’s proposed naming convention, view our article here).
FTC Concerns & Recommended Alternative
In response to the proposal, FTC published a comment as well as a press release, suggesting that “FDA’s naming convention, which departs from the FDA tradition, may cause physicians to believe mistakenly that the products necessarily have clinically meaningful differences, potentially resulting in reduced price competition in biologic drug markets.” FTC further stated that the FDA’s proposed naming convention could produce unnecessary costs and conflicts with efforts toward global naming harmonization.
Providing an alternative, FTC suggested the use of trade names rather than suffixes in distinguishing between non-interchangeable biosimilars and reference biologics. The press releases states that FTC is asking FDA to “reconsider its proposal and suggests alternatives with less impact on competition that could achieve FDA’s purpose to avoid inadvertent substitution and improve the reporting of adverse events involving biologics to the FDA.”
January 12, 2016
On January 4, 2016, the FDA published a draft guidance entitled, “Unique Device Identification: Convenience Kits.” The draft guidance comes after the Agency’s 2013 final rule that established a...
November 16, 2018
On Tuesday, November 13th, FDA proposed to add an exception to its informed consent requirements for minimal risk FDA-regulated clinical investigations. Under the Agency’s current regulations,...
August 16, 2016
On August 9, 2016, the FDA issued five public notifications advising consumers not to purchase or use a number of products, including: Citrus’ Fit Adelgazantes R-II Boss-Rhino Gold X-tra Strength...