EirGenix announced on the 19th that its licensing partner, Sandoz, has resubmitted the Biologics License Application (BLA) for EG12014, a trastuzumab biosimilar lyophilized injection (150 mg), to the U.S. Food and Drug Administration (FDA) for review.

EG12014 is EirGenix’s biosimilar to the breast cancer treatment Herceptin, originally developed by Roche. In 2024, global sales of Herceptin reached 1.38 billion Swiss francs, with the U.S. and European markets accounting for 41%. Although Roche’s global Herceptin sales have declined in recent years due to increased competition from biosimilars, overall global demand for trastuzumab-based products continues to grow, driven by a rising number of breast cancer patients and broader clinical adoption of biosimilars.

According to a report by Research and Markets, global sales of trastuzumab biosimilars have reached USD 4.27 billion in 2024.

EirGenix noted that EG12014 (branded as “Yi-Kang-Ping” in Taiwan), in its 150 mg lyophilized injection form, was approved by Taiwan’s TFDA in May 2023 and is covered by the National Health Insurance at a reimbursement price of NT$11,323 per vial. In November 2023, it also received marketing authorization from the European Commission (EC).

However, the path to FDA approval in the U.S. has been challenging. A previous application was returned due to issues found during facility inspection. Now, with this renewed submission by Sandoz, the industry is closely watching to see if EG12014 can finally secure approval in the critical U.S. market.

Resource: 捲土重來！台康生授權夥伴Sandoz 向FDA遞交EG12014藥證申覆審查