Emerging patient safety issues under health care reform: follow-on biologics and immunogenicity.

Ther Clin Risk Manag · 2011 · PMC3253755 · PMID 22241945

Europe PMC DOI

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may be significantno p-value reported

As such, there may be significant risk that such biologic product may create immunogenicity due to modification in manufacturing processes and other unforeseen changes compared to its original production.

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Quoted from the open-access full text in Europe PMC under the licence the publisher applied. The sentence is reproduced exactly as published; the emphasis is ours.