FDAnews Drug Daily Bulletin

While the FDA stayed true to its previous advice in the three draft biosimilars guidances released earlier this month, experts appear in conflict over how “abbreviated” the approval pathway is. The only required clinical study appears to be a human immunological study, possibly quelling industry concerns that clinical trial requirements would be the most cost-intensive step of the 351(k) pathway authorized by the 2010 Affordable Care Act.
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