EU Acceptance Of Foreign Comparators For Biosimilar Applications Will Boost Industry
This article was originally published in The Pink Sheet Daily
The European Union has announced that it will accept a reference product for a biosimilar application from countries with robust regulatory systems and similar guidelines, a move that should significantly boost the domestic biosimilars industry.
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Some data from a non-European version of a reference product can be used in biosimilar marketing applications, a revised overarching biosimilars guideline from European regulators says. It also notes interchangeability is a matter for individual European countries to decide.
As Europe gears up to approve and publish a global development plan for biosimilars, doctors’ reluctance to support extrapolation of indications for these drugs could be costly stumbling block for industry.
Industry applauds a suggestion by a senior healthcare representative that the European Commission could re-examine the overarching guideline on biosimilars to promote global development, but growth ultimately will be determined by greater worldwide harmonization.