Search results for biopharmaceutical

Comment on ‘Misinformation about interchangeable biosimilars’

Author byline as per print journal: Hillel P Cohen, PhD; Caridad Pontes, MD, PhD; Fernando de Mora, MBA, PhD Abstract: The critique of Reilly and McKibben of the meta-analysis conducted by Herndon et al. is factually flawed on several important points. As a result, the conclusions of Reilly and McKibben are not scientifically substantiated. Submitted: […]

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Biologicals and biosimilars: a review of the science and its implications

Abstract: Biopharmaceuticals are medicines whose active drug substance is made by living cells. Copies of these drugs, called biosimilars, are not identical to their reference drug and therefore specific regulatory requirements for registration apply. Whereas pharmaceutical quality evaluation requires a full dossier and a detailed comparative analysis to the reference drug, non-clinical and clinical requirements […]

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