Xbrane’s Ranibizumab Marches On With US FDA Filing Imminent
Swedish Firm Reveals Further Phase III Data For Proposed Lucentis Biosimilar
With Samsung Bioepis already holding US and EU approvals for biosimilar ranibizumab, Swedish sponsor Xbrane Biopharma says 12-month Phase III data supports ongoing registration of the Lucentis rival in both regions.
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Bioeq’s Ranivisio ranibizumab biosimilar has gained European Commission authorization for all innovator indications including wet AMD, the leading cause of blindness among over-65s.
Xbrane has set out its plans to resubmit its application for a biosimilar rival to Lucentis in the US, after receiving details from the FDA on additional information needed for the agency to accept the BLA for review.
Xbrane Biopharma has withdrawn the BLA for its proposed Xlucane ranibizumab biosimilar rival to Lucentis in the US after the FDA said further information was required for it to accept the filing. Development partner Stada said it would “work closely” with Xbrane and US licensee Bausch + Lomb to get the product to market.