Prestige Plans ‘Strong Price Competitiveness’ For Its Adalimumab Biosimilar
Discloses Phase I Details And Phase III Plans Ahead Of Filings In EU And US
As Prestige BioPharma announced plans for Phase I and Phase III trials of its PBP1502 proposed adalimumab biosimilar, as well as expected filing dates in the EU and US, the company outlined how it believes its proprietary technology will allow its Humira rival to compete aggressively on price.
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Prestige BioPharma says its proposed Tuznue trastuzumab rival to Herceptin is moving closer to launch in global markets, after reporting positive Phase III data for the biosimilar as well as a European GMP certification for its manufacturing facility in Korea.
Uptake is expected to be “rapid” once Humira biosimilars launch in the US, according to Sean McGowan, senior director of biosimilars at AmerisourceBergen. Meanwhile, milestone first approvals for interchangeable and ophthalmic biosimilars show that the US biosimilars market is moving in the right direction, he tells Generics Bulletin in an exclusive Q&A.
Prestige BioPharma has announced a memorandum of understanding with the city of Busan, in South Korea, to build a 45,000 sq m R&D center, including to “accelerate the development of innovative antibody drugs.”