1. Generics Bulletin

FDA Official Foresees Reduced Biosimilar Data Burden

Deep Product Understanding Expected To Move Regulators To Reduce Clinical Data Requirements

 
• By Derrick Gingery

New guidance from UK's MHRA saying comparative clinical efficacy studies typically will not be needed is a start, but other regulators may need a few years before adopting similar rules.

Insulin injectors with blood sugar chart
Insulin biosimilars are one example where the FDA determined comparative clinical immunogenicity studies were not necessary • Source: Alamy

New UK guidelines may represent a first step toward harmonized global biosimilar development programs without clinical efficacy studies if legal and other hurdles can be overcome.

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