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Biosimilars: EMA accepting non-EU reference products may lower development cost
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Going global in biosimilars
By Stephen Hansen
Senior Writer
Published on
Monday, July 9, 2012
The European
Medicines Agency and European Commission have taken steps that will
make it easier for biosimilars developers to run global development programs.
The changes should save time and money in cases where manufacturing and
clinical endpoints can be aligned across regulatory spheres.
Last month, the EC revised its
interpretation of biosimilars legislation to allow EMA to accept clinical data
for reference products approved outside the EU. Also, EMA released final
guidance that may reduce the clinical development requirements for biosimilar
mAbs.
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