# FDA CRL - Celltrion Inc. - Unknown Date

Source: https://www.keypedia.com/records/crl/celltrion-inc/0763a33e-2365-43bd-9c70-1bdec22e4f9c

> FDA CRL for Celltrion Inc. on Unknown Date. Product: BLA. Access full analysis and detailed observations.

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## Details

- Record Type: CRL
- Company Name: Celltrion Inc.
- Product Type: BLA
- Office Name: Division of Hematology Products
- Summary: The FDA issued a Complete Response Letter (CRL) to CELLTRION, Inc. for its Biologics License Application (BLA) 761088 for CT-P10, a proposed biosimilar to US-licensed Rituxan. The application cannot be approved in its present form due to unresolved deficiencies identified during a recent manufacturing facility inspection, significant clinical study concerns, and numerous product quality issues.

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## Related Officers

- [Jeffrey Fairbairn](https://www.keypedia.com/people/jeffrey-fairbairn/bae63fe2-fa41-4b55-9743-745ee93081c3)

Company: https://www.keypedia.com/companies/celltrion-inc/d3991ec8-423b-4554-9d67-72bc27a8658b

Office: https://www.keypedia.com/offices/division-of-hematology-products/5377b0a5-f20b-4047-a290-69428824917d