Opinion: A Modified 351(a) Licensing Pathway for Biosimilars
August 21st 2021
By Sarfaraz K. Niazi, PhDArticle
Use of the 351(k) biosimilar approval pathway entails legal challenges, high costs, and potentially higher clinical evidence standards. Sarfaraz K. Niazi, PhD, suggests that using the 351(a) pathway for standalone drugs and copy products may be faster and better. This is part 3 of a series.