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Biosimilars require more robust analytical data

At Biosimilar Drug Development conference recently held in London, Mark McCamish / Head Global Biopharmaceutical Development at Sandoz presented latest trends of the ever changing regulatory framework for Biosimilars and stressed the need for more robust biosimilarity data. This trend follows the release of the new FDA Guidelines and will have its impact on EMA as well. The better a Biosimilar can be characterized the less stringed will be requirement for subsequent clinical trials and by thus will help to reduce overall cost. Medizone Germany is specialized in the sourcing of reference products and can offer their service to existing and potentially new developers of Biosimilars.