On December 10, EirGenix announced that the U.S. Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) to Sandoz, its exclusive licensing partner, regarding the biologic license application (BLA) for the biosimilar EG12014 lyophilized injection (150 mg). The CRL highlighted deficiencies related to manufacturing processes and facilities identified during a pre-approval inspection (PAI). This means the market entry of this EirGenix-developed biosimilar breast cancer treatment in the U.S. will face further delays.

Manufacturing Issues Highlighted in the CRL, Product Quality Unaffected

EirGenix stated that the FDA accepted the BLA for EG12014 in June 2024, and a pre-approval inspection was conducted in late October at a third-party contractor's aseptic filling and freeze-drying facilities. The issues outlined in the CRL are specific to the contractor’s manufacturing processes and do not concern product quality, clinical efficacy, safety, or biosimilarity.

Sandoz is collaborating closely with the FDA and EirGenix to address the deficiencies as quickly as possible. Notably, the U.S. market primarily requires the 420 mg dosage format. Sandoz plans to include both the 150 mg and 420 mg versions in its resolution strategy, aiming for simultaneous approval and market launch. This ensures the timely availability of this critical medication for U.S. patients.

Global Market Progress Remains Unaffected

EirGenix clarified that the CRL pertains only to the U.S. launch of EG12014 and does not impact approvals in other markets. The product is already approved and available in Europe and Taiwan. In Europe, where the 420 mg dosage accounts for two-thirds of the market demand, Sandoz secured approval for the 150 mg dosage in November 2023. Once the 420 mg version receives approval, Sandoz will promptly introduce it across European markets.

In Taiwan, EirGenix has completed three validation batches of the 420 mg formulation through Tai Yao Chemical (4746) and is actively preparing the necessary documentation to submit for regulatory approval to the Taiwan FDA (TFDA). Additionally, EirGenix is progressing licensing agreements with potential partners in countries where it holds marketing rights for the product.

A Significant Step in Biosimilar Development

EG12014, also known as Trastuzumab Biosimilar, is a monoclonal antibody treatment targeting HER2-positive breast cancer and metastatic gastric cancer. In April 2019, EirGenix entered into an exclusive global licensing agreement with Sandoz, excluding Taiwan, Russia, China, Australia, and selected Asian and South American countries. The agreement includes an upfront payment, milestone payments, and royalties based on product sales.

Despite the current setback in the U.S., EirGenix remains committed to optimizing manufacturing processes and resolving regulatory issues. With approvals already underway in other regions, the company is poised to continue expanding access to this critical biosimilar therapy for patients worldwide.

Resource: 台康乳癌藥美國上市再等等 Sandoz收到FDA完全回覆信函