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 BioPharma ("Prestige") has reached a licensing agreement with Cipla Limited ("Cipla") 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 European Medicines Agency (EMA) and United States Food and Drug Administration (USFDA) in 2019.

This agreement will leverage Cipla’s strong local presence, sales and marketing capabilities in these 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.

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