Prestige BioPharma and Alvogen today 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 (CEE).

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.

Lisa S. Park, CEO of Prestige BioPharma, commented: “We are pleased to partner with Alvogen to commercialize our lead biosimilar program in Central and Eastern Europe. It is an important step towards our mission to become a leading global biosimilars and biopharmaceuticals development company.“

Hacho Hatchikian, Executive Vice President of Alvogen CEE, added: “I am pleased to partner with Prestige BioPharma to further expand our biosimilar portfolio in the region. Alvogen is poised to capitalize on the biosimilar opportunities, with a 450-people-strong sales & marketing network covering over 20 CEE markets. We have managed to secure a leading position in biosimilars in the region, with a robust portfolio of leading molecules for the treatment of oncology, rheumatoid arthritis and anemia and the expected addition of Trastuzumab biosimilar (HD201; Hervelous) will be a great addition to our biosimilar assets.”