Pharmapark Will Market Prestige's Trastuzumab In Russia
Prestige BioPharma has struck a deal with Pharmapark to market Prestige’s trastuzumab biosimilar in the Russian Federation.
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Blow For Prestige As Trastuzumab Biosimilar Rejected By EMA
Prestige Biopharma has received a setback in its attempts to win a European approval for its HD201 trastuzumab biosimilar rival to Herceptin, after the EMA’s CHMP issued a negative opinion on its parallel marketing authorization applications under the Tuznue and Hervelous labels. Prestige has 15 days in which it can ask for a re-examination of the refusals.
Phase III Data And GMP Nod Bring Prestige’s Trastuzumab Closer To Launch
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.
Dr Reddy’s To Market Prestige's Trastuzumab Across Latin America And Southeast Asia
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.