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Lupin Announces FDA Acceptance of aBLA for Pegfilgrastim Biosimilar

Global pharmaceutical company Lupin Limited recently announced that the U.S. FDA has accepted its aBLA for a proposed pegfilgrastim biosimilar (reference product Neulasta®).  Lupin reported that the aBLA submission was supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies.  Company CEO Vinita Gupta commented, “FDA’s acceptance of our…

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