Prestige Takes Trastuzumab A Step Closer To US Filing
As Major Shareholder Invests Further In Singapore-Based Biosimilars Developer
Executive Summary
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.
You may also be interested in...
Pfizer Interest In Biosimilars Appears To Decline As Firm Ceases To Split Out Segment
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 And Intas Strike International Bevacizumab Deal
Prestige Biopharma and Intas Pharmaceuticals have announced a commercialization deal for Prestige’s HD204 proposed bevacizumab biosimilar, covering a range of territories including markets in the Americas, Europe, Africa and Asia.
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.