Amgen Inc. – FDA CRL

The FDA issued a Complete Response Letter (CRL) to Amgen Inc. for its Biologics License Application (BLA 761073) for Kanjinti (ABP 980), a proposed biosimilar product. Submitted under section 351(k) of the Public Health Service Act, the application could not be approved due to several deficiencies. A primary issue involved unsatisfactory resolution of deficiencies identified during a recent inspection of a manufacturing facility.

Further requirements include significant revisions to the proposed prescribing information, ensuring compliance with PLR requirements and guidance for biosimilar products, and resubmission of draft carton and container labeling based on FDA's proposed revisions. While the proprietary name, Kanjinti, was found acceptable, it must be resubmitted with the corrected application.

Amgen must also provide a comprehensive safety update, detailing any significant changes in the safety profile, presenting new and combined clinical safety data, including case reports for patient deaths or serious adverse events, and offering an updated summary of worldwide safety experience with foreign labeling. Additionally, recommendations include implementing a FeyRIIla binding test, further characterizing Fc functions, and providing sterilization and media fill validation data. Amgen is required to fully address all deficiencies and resubmit the application within one year, as the product cannot be legally marketed until written approval is granted.