Earlier this month we reported that FDA had published a notice in the Federal Register soliciting comments on a proposed biologic naming guidance whereby applicants for biologic products would submit up to 10 proposed four-letter suffixes and, optionally, analyses supporting those suffixes. FDA has now announced that it is withdrawing…
FDA recently proposed a new biosimilar naming convention, whereby the nonproprietary name for a biological product would require a new, random four-letter suffix. The new naming convention is in the spirit of emphasizing that biosimilars, unlike generic drugs, are not replicas of their biologic counterpart. In its response to the…
On September 17, 2015, Janet Woodcock, M.D., the director of the FDA’s Center for Drug Evaluation and Research, testified at a congressional hearing on the topic of biosimilars. A link to her written testimony is provided here, and a link to the video of the Q&A session is provided here….
In a move that may impact the continuing debate over how to name and label biosimilar biologics, the World Health Organization (“WHO”) has released a new draft of its proposal for assignment of Biological Qualifiers (“BQ”). The BQ proposal aims to standardize naming of biologics by giving each approved and marketed…