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# FDA Rejects Mylan’s BLA for Neulasta Biosimilar
- URL: https://www.fdaweb.com/fda-rejects-mylans-bla-for-neulasta-biosimilar/
- Published: 2017-10-10T12:00:00.000Z
- Updated: 2026-09-14T22:55:11.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5139831

FDA has issued a complete response letter for Mylan´s BLA for MYL-1401H, a proposed biosimilar of Amgen’s Neulasta (pegfilgrastim). The letter relates to a “pending update of the BLA with certain \[chemistry, manufacturing and controls\] data from facility requalification activities post recent plant modifications,” according to the company. It did not raise any questions on biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data or immunogenicity, it adds. Mylan does not expect the agency action to impact the product’s commercial launch timing.

Novartis was recently issued a complete response letter for its biosimilar of Neulasta too.