Prestige BioPharma has reached a licensing agreement with Cipla Limited for its trastuzumab biosimilar (HD201) under which Cipla will have exclusive rights to distribute and market the drug in selected emerging markets.
HD201 is a mAb biosimilar to Roche’s Herceptin, which is used to treat patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Prestige’s HD201 is in Phase 3 clinical development for filing with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration in 2019.
This agreement will leverage Cipla’s local presence, sales, and marketing capabilities in the emerging markets.
Prestige will be responsible for full development, product registration with EMA, and commercial supply of HD201 out of its manufacturing facilities in Osong, South Korea.
“With this partnership, we made another important step towards a broad global availability of our trastuzumab biosimilar product,” Lisa S. Park, Prestige chief executive officer said in a press statement.
(Source: Prestige BioPharma)
Filed Under: Oncology
