SINGAPORE, Aug. 1, 2024 /PRNewswire/ -- Prestige Biopharma, a pioneer in biopharmaceuticals, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for Tuznue®, a Herceptin (trastuzumab) biosimilar. This milestone positions Prestige Biopharma to become the first Singaporean firm to commercialize its biosimilar in the European Union.
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SINGAPORE--(BUSINESS WIRE)--Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, has submitted a request to the U.S. Food and Drug Administration (FDA) for a pre-submission meeting to discuss the company’s planned Biologics License Application (BLA) for its Herceptin Biosimilar, HD201(Tuznue®).
SINGAPORE--(BUSINESS WIRE)--Prestige Biopharma Limited (KRX: 950210, hereafter referred to as “Prestige”) and Intas Pharmaceuticals Limited (hereafter referred to as “Intas”) 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 bevacizumab biosimilar, in the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan.
Singapore-based Prestige Biopharma has received approval from the US Food and Drug Administration (FDA) for the Phase I/IIa clinical trial of PBP1510 to treat pancreatic cancer, an aggressive malignancy.
SINGAPORE--(BUSINESS WIRE)--Prestige Biopharma Limited, a Singapore-based biopharmaceutical company with operations in USA and South Korea, announced that the U.S. Food and Drug Administration (FDA) has approved the Phase 1/2a clinical trial of its first-in-class anti-PAUF monoclonal antibody, PBP1510 (INN: Ulenistamab), for the treatment of pancreatic cancer.
Prestige BioPharma’s recent failure to get European approval for its Herceptin biosimilar could have resulted from the company’s changes in the manufacturing of the biosimilar during a phase-3 trial, the company said.
SINGAPORE--(BUSINESS WIRE)--Prestige Biopharma Limited and Vaxine Pty Ltd announced that the two organizations have entered into a memorandum of understanding (MOU) to collaborate on the supply of Vaxine’s COVID-19 Vaccine, Covax-19® (also known as Spikogen®) and on the co-development of COVID-19/influenza combo vaccine.