Eye on Pharma: Prestige BioPharma, Alvogen Reach Commercialization Agreement for Trastuzumab Biosimilar

Prestige BioPharma and Alvogen have recently announced that they have entered into an exclusive partnership for the commercialization of Prestige BioPharma’s trastuzumab biosimilar in Central and Eastern Europe.

The proposed trastuzumab biosimilar will be seeking indications to treat human epidermal receptor 2 (HER2)-positive breast cancer, as well as HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. The potential biosimilar is currently in phase 3 clinical development and will be marketed as Hervelous.

“I am pleased to partner with Prestige BioPharma to further expand our biosimilar portfolio in the region… 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 [a] trastuzumab biosimilar will be a great addition to our biosimilar assets,” commented Hacho Hatchikian, executive vice president of Alvogen.

The agreement includes the exclusive rights for Alvogen to commercialize the proposed biosimilar in all of its Central and Eastern European markets. Although the exact terms of the arrangement have not been publicly disclosed, Prestige BioPharma will assume the responsibility of development and product registration with the European Medicines Agency (EMA), as well as the commercial supply of the biosimilar out of its manufacturing facilities in Osong, South Korea.

The companies plan to file with the EMA and the FDA for regulatory approval in 2019.