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Prestige Biopharma Withdraws the MAA for HD201 (biosimilar, trastuzumab) from the EMA

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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

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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