Revised EMA guideline on biosimilar LMW heparins loosens efficacy data requirements
This article was originally published in SRA
Executive Summary
The European Medicines Agency has issued a draft guideline on biosimilar low molecular weight heparins that updates its earlier 2009 guideline and introduces a number of changes that could benefit generics firms eyeing up this space1,2. Among the changes is the possibility of waiving clinical efficacy trials – albeit only in exceptional circumstances – and preclinical in vivo studies.