FDA First Biosimilar Approval

We are very pleased to announce the approval of the first biosimilar by the FDA of Zarxio (filgrastim-sndz). Our company provided support in FDA pre-inspection preparations for about 2,5 months for a total of 5 FDA inspection.

The FDA press announcement states that the abbreviated licensure pathway under section 351(k) of the Public Health Service Act permits reliance on certain existing scientific knowledge about the safety and effectiveness of the reference product, and enables a biosimilar biological product to be licensed based on less than a full complement of product-specific preclinical and clinical data. A biosimilar product can only be approved by the FDA if it has the same mechanism(s) of action, route(s) of administration, dosage form(s) and strength(s) as the reference product, and only for the indication(s) and condition(s) of use that have been approved for the reference product. The facilities where biosimilars are manufactured must also meet the FDA?s standards.

The full FDA press announcement can be found here: Click Here



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