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Lupin gets US-FDA nod for its Pegfilgrastim biosimilar application

The Biologics License Application (BLA) submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies........................

USFDA accepts Mylan & Biocon’s proposed biosimilar Pegfilgrastim for review

The development marks the second successful biologics license application (BLA) for filing of the partnership in the United States of America...