Phase III Data And GMP Nod Bring Prestige’s Trastuzumab Closer To Launch
Latest Developments Bode Well For Tuznue Biosimilar Rival To Herceptin
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.
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Still reeling from the EMA’s recent rejection of its biosimilar trastuzumab candidate, Prestige BioPharma’s management have bought up more shares in the company, insisting that the “recent fall in stock price doesn’t reflect the potential value” of the firm.
Prestige BioPharma has made the latest commercialization partnership for its proposed trastuzumab biosimilar, with Dr Reddy’s now in place to market the drug across select nations in Latin America and Southeast Asia.
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.