FDA Issues CRLs to Celltrion for Two Biosimlars

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Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

On April 6, 2018, Celltrion issued a statement that it received Complete Response Letters (CRLs) from FDA for the biologics license applications for CT-P10 (rituximab), a proposed biosimilar to Roche’s Rituxan/MabThera (rituximab), and CT-P6 (trastuzumab), a proposed biosimilar to Roche’s Herceptin (trastuzumab).

The CRLs stem from a warning letter that FDA issued to Celltrion on Jan. 26, 2018 after an inspection carried out from May 22 to June 2, 2017 at Celltrion’s drug manufacturing facility in Incheon, South Korea. The letter raised issues related to certain manufacturing process at the facility. 

According to the warning letter, Celltrion failed to establish and follow appropriate written procedures designed to prevent microbiological contamination and ensure product sterility, including validation of all aseptic and sterilization processes. The warning letter also stated that the company failed to thoroughly investigate unexplained discrepancies/failures of batches and to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

The company is making progress addressing the concerns raised by FDA in the warning letter and is committed to working with the agency to fully resolve all outstanding issues with the highest priority and urgency, Celltrion said in its statement relating to the CRLs. The company expects that the issues will be resolved in a timely manner.


“We can confirm that the resubmission will be in-place relatively soon. Then, we are expecting approvals in [six] months after resubmission according to [the] regulatory timeline,” according to the company in its statement.

The warning letter does not affect the company’s ability to manufacture and supply the Inflectra (infliximab-dyyb) products from its Incheon site, and the company does not currently anticipate any impact on the supply of Inflectra (infliximab-dyyb) based on the letter, the company said in a Feb. 1, 2018 statement

Source: Celltrion