Samsung Bioepis to initiate phase 3 trials of Lucentis biosimilar
[THE INVESTOR] Korea’s biopharmaceutical firm Samsung Bioepis is set to begin late-stage clinical trials of its copy version referencing Novartis’ eye drug Lucentis in Korea
The Ministry of Food and Drug Safety approved the initiation of phase 3 clinical trials of the biosimilar candidate SB11 on Sept. 18.
The study will be conducted on 140 patients with wet age-related macular degeneration to compare efficacy and safety between SB11 and Lucentis. The brand name drug posted global sales of US$3.3 billion in 2016.
Lucentis has long been targeted by Korean bio startups like BIOCND and Polus, which jumped on the biosimilar bandwagon to make a copy.
To fend off the competition, Novartis has been pushing to expand indications of Lucentis.
In the latest upgrade, the US Food and Drug Administration approved the eye treatment for all forms of diabetic retinopathy in April.
By Park Han-na (firstname.lastname@example.org)