Prestige Biopharma voluntarily withdraws EMA application for HD201, biosimilar trastuzumab (Herceptin®)

Korea Biomedical Review reported that Prestige Biopharma has voluntarily withdrawn its EMA application for the HD201 (Tuznue®, biosimilar trastuzumab).  Prestige received a negative opinion from the CHMP in May 2022, with the CHMP taking the view that the manufacturing process used for the commercial production of these medicines differed from that used during clinical testing.  Prestige reportedly was not able to establish equivalence in a requested re-examination by CHMP.  Prestige has represented that following withdrawal, it will supplement its data and resubmit with EMA this year.