A biosimilar sponsor’s ability to secure an interchangeability determination may be complicated by performance and design differences in the delivery devices for the biosimilar and reference product, FDA review documents for Sandoz Inc.’s Zarxio (filgrastim-sndz) suggest.
In its review of Sandoz's 351(k) application, the agency raised concerns about the ability of patients and caregivers to administer partial doses from the current prefilled syringe for Zarxio, a...
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