Prestige Pulls Trastuzumab After EMA Knockback
Formal Withdrawal Of MAA Follows CHMP Negative Opinion And Re-Examination
Prestige Biopharma has formally withdrawn its marketing authorization application for its Tuznue (trastuzumab) biosimilar candidate, following a negative opinion from the EMA’s CHMP as well as a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.
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Pfizer appears to be maintaining its “opportunistic” approach to biosimilars, having ceased to split out the business unit’s results during its Q3 earnings report.
Still reeling from the EMA’s recent rejection of its biosimilar trastuzumab candidate, Prestige BioPharma’s management have bought up more shares in the company, insisting that the “recent fall in stock price doesn’t reflect the potential value” of the firm.