WHO Draft Guidelines On Biosimilar MAbs: Extrapolation 'A Goal' Of Development Program
This article was originally published in SRA
The World Health Organization has launched a public consultation on proposed draft guidelines1 for the evaluation of biosimilar monoclonal antibodies (MAbs) to complement its existing 2009 guidance on "similar biotherapeutic products" (SBPs)2. Comments are invited until April 5.
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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.