EirGenix Biologics announced on the 12nd that its licensing partner, Sandoz, received a Complete Response Letter (CRL) from the U.S. FDA regarding the BLA for EG12014 (a biosimilar to Roche’s Herceptin).

• Root Cause: While the FDA raised no concerns regarding clinical efficacy, safety, or biosimilarity, it identified manufacturing defects during a pre-approval inspection (PLI) at Sandoz’s own lyophilization (freeze-drying) facility conducted in September 2025.
• Status in Other Markets: The 150mg dosage has already been approved in the EU (under the brand Herwenda) and Taiwan. EirGenix noted that the U.S. delay does not affect these markets. Furthermore, Sandoz successfully transferred production to its own plant for the EU market in late 2025.
• Next Steps: EirGenix and Sandoz are working closely with the FDA to resolve the facility issues to secure the BLA. Meanwhile, EirGenix is progressing with reimbursement applications for the 420mg version in Taiwan.

Resource: 台康乳癌相似藥向美叩關再受挫，授權夥伴Sandoz藥品生產缺失待改善