Aprogen gets OK Phase 3 trials in India for Herceptin biosimilar

South Korea’s biopharmaceutical company Aprogen Inc. announced on Monday that its Phase 3 clinical trial for a biosimilar of Herceptin (trastuzumab) AP063 got approval from to India's Central Drugs Standard Control Organization (CDSCO).

In October last year,  Aprogen sought permission from the European Medicines Agency (EMA) to conduct Phase 3 clinical trials on 720 patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer.

These trials aim to demonstrate the equivalence of AP063 to Herceptin in terms of efficacy, safety, and immunogenicity (the ability to induce an immune response).

In November last year, Aprogen submitted an identical application for phase 3 trials to India's CDSCO.

"We plan to file for marketing approval not only in India but also with the US Food and Drug Administration (FDA) and other countries beyond Europe," an Aprogen source said. 

Write to In-Hyuk Park at hyuk@hankyung.com