Prestige Biopharma Pte. Ltd.
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Latest From Prestige Biopharma Pte. Ltd.
Pfizer appears to be maintaining its “opportunistic” approach to biosimilars, having ceased to split out the business unit’s results during its Q3 earnings report.
Prestige says a meeting with the FDA in November represents a “final step” before filing its trastuzumab biosimilar with the US agency by the end of the year. Meanwhile, a major shareholder has invested further in the Singapore-based biosimilars developer.
The European Medicines Agency has delivered its verdict on marketing applications for a raft of new medicines.
Prestige Biopharma has formally withdrawn its marketing authorization application for its Tuznue (trastuzumab) biosimilar candidate, following a negative opinion from the EMA’s CHMP as well as a requested re-examination.
- Large Molecule
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