Samsung Bioepis Co., Ltd – FDA CRL

The U.S. FDA issued a corrected provisional determination letter to Samsung Bioepis Co., Ltd. concerning its Biologics License Applications (BLAs 761373/Original 2 and 761425/Original 2) for Pyzchiva (ustekinumab-ttwe) injection, an interchangeable biosimilar to Stelara (ustekinumab). The effective action date for this determination is June 28, 2024.

Operating under section 351(k) of the Public Health Service (PHS) Act, the FDA provisionally concluded that Pyzchiva meets the established interchangeability criteria. However, final approval cannot be granted currently because of an unexpired period of exclusivity designated for the first interchangeable biosimilar product. The agency explicitly stated that no other deficiencies warranting a complete response action were identified, signifying the application's compliance with established standards.

To obtain approval, Samsung Bioepis must submit an amendment, clearly labeled "REQUEST FOR APPROVAL," no more than six months prior to the exclusivity period's expiration. This submission should outline the legal and regulatory basis for approval and include any updates to labeling, chemistry, manufacturing, and controls data, or risk evaluation and mitigation strategies. If no changes, this must be stated.

Furthermore, a postmarketing commitment for BLA 761425 mandates the development and submission of an endotoxin testing method to mitigate the low endotoxin recovery (LER) effect, including method qualification and LER study results, with a final report due by January 2026. Pediatric assessment requirements are detailed in separate correspondence.