Going global in biosimilars

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...