Companies agree to commercialise trastuzumab biosimilar in central and eastern Europe

Singapore-based biopharmaceutical company, Prestige Biopharma, and privately-owned pharma company, Alvogen, have entered a license and supply agreement to commercialise trastuzumab biosimilar (Hervelous) in central and eastern Europe.

The binding agreement includes the exclusive rights for Alvogen to commercialise Prestige BioPharma’s Hervelous (trastuzumab) in all of its central and eastern European markets. Although the terms of the deal have not been disclosed, it has been reported that Prestige BioPharma will assume responsibility for full development, product registration with EMA, and commercial supply of Hervelous, from its manufacturing facilities in Osong, Korea.

Hervelous is a mAb biosimilar to trastuzumab — Roche’s Herceptin — which is used to treat patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Currently in Phase III clinical development, the biosimilar is expected to undergo filing with the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) next year (2019).

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

“I am pleased to partner with Prestige BioPharma to further expand our biosimilar portfolio in the region,” commented Hacho Hatchikian, executive vice president of Alvogen CEE. “Alvogen is poised to capitalise 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 anaemia and the expected addition of trastuzumab biosimilar (HD201; Hervelous) will be a great addition to our biosimilar assets.”