Market CompetitionManagement noted there has been greater price compression in the branded anti-VEGF market in Europe (€400-€1,000 per dose in the EU versus $2,000 in the US market).
Product Quality ConcernsCompounded bevacizumab leaves much to be desired, as there are prevailing concerns surrounding manufacturing quality with implications ranging from diminished efficacy to potentially life-changing adverse events.
Regulatory IssuesThe FDA issued a Complete Response Letter for the BLA for ONS-5010, citing several CMC issues and open observations from pre-approval manufacturing inspections.