Prestige Biopharma Withdraws the MAA for HD201 (biosimilar, trastuzumab) from the EMA
Shots:
- The company withdrew its MAA for HD201 (biosimilar, trastuzumab) that was submitted to the EMA and plans to re-submit the MAA with supplement data of additional tests & analysis
- In May 2022, Prestige requested a re-examination of its MAA for the HD201 after receiving a negative opinion from the EMA’s CHMP due to variance in the range of acceptance for the criteria of analytical comparability b/w clinical testing batch & commercial production batch of HD201
- Currently, the MAA for HD201 is under Health Canada and MFDS Korea’s review & will submit an MAA to the US FDA at the end of 2022. Prestige focuses on the reapplication of the MAA to EMA for HD201
Ref: Prestige | Image: Prestige
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