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 has announced that its Prolia/Xgeva (denosumab) biosimilar, SB16, has begun Phase I clinical trials. Further, the company’s Lucentis (ranibizumab) biosimilar, SB11, has produced positive Phase III data and has been filed in the US. Meanwhile, CEO and president Christopher Hansung Ko has commented on the impact of the coronavirus pandemic on the industry and competition from domestic companies in the Chinese market.
An advanced immunotherapy for recurrent glioblastoma and the first biosimilar version of Lucentis for age-related macular degeneration have also been submitted for review by the European Medicines Agency for potential pan-EU authorization.
Sweden’s Xbrane is aiming to file for approval of its Xlucane (ranibizumab) biosimilar to Lucentis in Europe and the US, and license the rights for the product’s sale and marketing of in Latin America, Japan and China, in the next 12 months.