Earlier this week, FDA announced the availability of its
long-awaited draft guidance on biosimilar labeling, titled "Labeling for Biosimilar Products." In the
draft guidance, FDA advised that "biosimilar product labeling
[should] incorporate relevant data and information from the
reference product labeling, with appropriate product-specific
modifications." Notably, however, FDA believes that data
designed to demonstrate biosimilarity should not be included
because of their potential to cause confusion. The draft guidance
goes on to provide specific recommendations and examples related to
product identification (e.g., when to use the biosimilar name,
reference product name, core name, or a combination), content
presentation (i.e., specific to the biosimilar product's
conditions of use), and specific labeling sections. The draft
guidance concludes with information on drafting patient labeling,
updating safety information, seeking additional conditions of use,
and submitting initial and revised labeling. Interestingly, the
draft guidance leaves open the possibility of future direction for
labeling interchangeable biological products should they be
established. The draft guidance is the first biosimilar-specific guidance published
by FDA this year (Jones Day published Commentaries on
previous biosimilars guidance documents here,
here, and here).
The draft guidance comes weeks after FDA's "Deemed to be a
License" guidance, which we discussed in our last Jones Day Update, and one day before FDA announced approval of a second biosimilar
product. Given the biosimilar market's infancy, FDA recently stated that the "labeling
guidance has been issued in draft to provide an opportunity for
public comment." FDA compared the format to that used for the
recent draft guidance on nonproprietary naming, for which FDA is
currently reviewing comments. FDA affirmed its commitment to
finalizing both draft guidance documents but offered no deadline
for comments.
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