An FDA advisory committee's overwhelming endorsement of Amgen Inc.'s ABP 501 as a biosimilar to AbbVie Inc.'s TNF-inhibitor Humira (adalimumab) belied the struggle that many of the agency's external experts faced in understanding the basic concepts underlying the 351(k) regulatory pathway.
Amgen's Humira Biosimilar Gains Nod From Panel Perplexed By Regulatory Pathway
Time and again, FDA officials had to explain the importance of the analytical characterization data in the biosimilar development paradigm.