Prestige Management Fights Back Following Biosimilar Rejection
CEO And COO Buy Up nearly 140,000 Shares To ‘Reinforce Trust’
Prestige BioPharma’s top brass are looking to restore shareholder confidence following the surprise failure of their trastuzumab biosimilar before the EMA’s CHMP.
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Prestige Biopharma has formally withdrawn its marketing authorization application for its Tuznue (trastuzumab) biosimilar candidate, following a negative opinion from the EMA’s CHMP as well as a requested re-examination.
Prestige Biopharma says it is acting to “consolidate group competitiveness” by taking an increased share in Prestige Biologics, at the same time as a new CEO was appointed for the CDMO.
Following decisions by the EMA’s CHMP to deny Prestige Biopharma a marketing authorization for its trastuzumab biosimilar and to suspend the marketing authorizations of dozens of generics due to concerns over bioequivalence tests, the European regulator has confirmed it will review the opinions.