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Prestige Takes Trastuzumab A Step Closer To US Filing

As Major Shareholder Invests Further In Singapore-Based Biosimilars Developer

 
• By Dave Wallace

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.

Blue Steps Final Light
Prestige’s meeting with the FDA is the final step before filing • Source: Shutterstock

Prestige Biopharma says a meeting with the FDA in November represents a “final step” before filing its HD201 trastuzumab rival to Herceptin, also known as Tuznue, with the US agency by the end of the year.

Noting that the pre-submission biosimilar biological product development type 4 meeting would “discuss the format and content of a biologics license application in advance of the final submission,” the Singapore-based biosimilars developer said it would “discuss the

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