Prestige BioPharma and Alvogen announced that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige BioPharma´s Trastuzumab biosimilar (HD201; Hervelous™) in Central and Eastern Europe.

Hervelous™ is a mAb biosimilar to Roche’s Herceptin® (trastuzumab), which is used to treat patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Hervelous™ is in Phase-3 clinical development for filing with the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in 2019.

The partnership arrangement includes the exclusive rights for Alvogen to commercialize Hervelous™ (trastuzumab) in all of its CEE markets, leveraging the company’s strong sales and marketing capabilities and experience in successfully bringing new biosimilars to market.

Whilst the terms of the deal are not being disclosed, Prestige BioPharma will assume responsibility for full development, product registration with EMA, and commercial supply of Hervelous™, out of its manufacturing facilities in Osong, Korea.