Revised EMA guideline on biosimilar LMW heparins loosens efficacy data requirements
This article was originally published in SRA
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.
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A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.