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# FDA Holds Up 2 Celltrion Biosimilars
- URL: https://www.fdaweb.com/fda-holds-up-2-celltrion-biosimilars/
- Published: 2018-04-05T12:00:00.000Z
- Updated: 2026-09-14T23:57:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141151

FDA has issued complete response letters for two biosimilars — Truxima, a version of Roche’s Rituxan (rituximab), and Herzuma, a biosimilar of Roche’s Herceptin (tratsuzumab) — to be manufactured for Teva by Celltrion, a Korean pharmaceutical company. Celltrion said it was “committed to working with the regulatory agency to fully resolve all outstanding issues with an aim to receive approval this year.”

FDA issued a 1/26 [Warning Letter](https://www.fdaweb.com/cgmp-violations-at-koreas-celltrion/) to Celltrion following an inspection at the firm’s Incheon manufacturing facility that found violations of current good manufacturing practice regulations for finished pharmaceuticals and recommended that the company retain a consultant to assist it in meeting requirements.

BLAs for the two products were submitted 8/2017.