Eye on Pharma: Celltrion Resubmits BLA for Rituximab Biosimilar

Biosimilar developer Celltrion has resubmitted its Biologics License Application (BLA) for a proposed rituximab biosimilar, CT-P10, to the FDA for regulatory consideration. The company received a Complete Response Letter (CRL) for the drug in April 2018, after having received an earlier warning letter from the agency that raised concerns about the company’s manufacturing processes.

The warning letter detailed “poor aseptic behavior,” including an observation made during an inspection that an operator created the risk of microbial contamination during the aseptic filling of vials, and that, even after revising its aseptic technique procedures for setup and filling, Celltrion’s procedure allowed for contamination of product-contact surfaces followed by disinfection rather than preventing sterile equipment from becoming contaminated.

Other issues noted in the warning letter included smoke study deficiencies, media fill deficiencies, problems with vial stoppers, the presence of visible particles in finished drug product, and deficient environmental monitoring.

“Celltrion has made progress addressing the concerns raised by the 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,” said the company in a statement. It also noted that the FDA has notified the company of its reinspection schedule for the facility in question, and it has confirmed that it will resume the review procedure for biosimilars upon BLA resubmission.

Celltiron will also resubmit a BLA for its proposed trastuzumab biosimilar, CT-P6, to the FDA in June; the company received a CRL for the trastuzumab product on the same day as the CRL for the rituximab biosimilar. In a notice to shareholders, Celltrion explained that it hopes to obtain US approval for the 2 biosimilars before the end of 2018.

In the European Union, Celltrion’s rituximab and trastuzumab biosimilars are both authorized for marketing and are sold under the brand names Truxima and Herzuma, respectively.