Progress and Hurdles for Follow-on Biologics  

Oleh:

Sarpatwari, Ameet ; Avorn, Jerry ; Kesselheim, Aaron S.

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: The New England Journal of Medicine (keterangan: ada di Proquest) vol. 372 no. 25 (Jun. 2015), page 2380-2382.

Ketersediaan

Perpustakaan FK Nomor Panggil: N08.K Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

n March 2015, the Food and Drug Administration (FDA) approved filgrastim-sndz (Zarxio), Sandoz's version of the leukocyte growth factor Neupogen, an Amgen drug indicated for conditions including neutropenia in patients with nonmyeloid cancers and for stem-cell harvesting. Filgrastim-sndz is a follow-on biologic, a version of a protein-based drug made by a different manufacturer but approved for the same clinical indications; it was the first product in the United States authorized through the new regulatory pathway for follow-on biologics.

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