Notice: FDA to Up Recommendation on Amount of Biosimilar Suffixes

The FDA could be increasing its recommendation on the amount of proposed suffixes — from three to 10 — that biosimilars applicants can propose for their products.

While the FDA’s August 2015 draft guidance on biosimilars naming says that drugmakers should propose only up to three potential suffixes, a Federal Register notice released last week states that “the guidance recommends that applicants should submit up to 10 proposed suffixes.”

 “The final guidance on nonproprietary naming of biological products is still forthcoming and this notice, which is required under the Paperwork Reduction Act, and comment period is one of the steps in the process,” said FDA spokeswoman Sandy Walsh.