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    PhRMA, BIO Double Down on Biosimilar Naming With FDA Petition

    The nontrivial issue of how biosimilars should be named in the US may not go away until the US Food and Drug Administration (FDA) makes a definitive decision on how these new products should be labeled and tracked. On the one hand, these cost-saving biosimilars will need to be clearly distinguished from their reference product so that regulators can track any adverse events and ensure they are safe, though on the other side of the coin, any new labeling requirements coul...