Samsung Bioepis First To File EU Lucentis Rival
Confirms SB11 Ranibizumab Biosimilar Candidate Accepted For Filing By EMA
Samsung Bioepis has beaten its rivals to become the first firm to announce successful filing of a ranibizumab biosimilar rival to Lucentis in the EU.
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Samsung Bioepis is set to make waves with the first ophthalmic biosimilar after the European regulator recommended that its ranibizumab biosimilar Byooviz receive a pan-European marketing authorization.
Samsung Bioepis has been tight-lipped on the potential to win approval for its SB11 biosimilar ranibizumab product this year, though new similarity data is a further positive omen for the Korea-based biosimilar player.
Samsung Biologics has set out growth plans – including for its Samsung Bioepis biosimilars venture and its CDMO business – after its sales passed the KRW1trn threshold in 2020.