Samsung Bioepis – a joint venture between Samsung Biologics and US-based Biogen Idec – recently published a plan for its third phase of the study for the formula named SB11. If successful, the new formula is expected to impact on the US$3.8 billion (AU$5.04 b) a year sales that Swiss pharmaceutical company Roche generates from the best-seller drug.Clinical trials for SB11 are scheduled to start in Septber with clinical ophthalmologist Dr Woo Se-jun from the Seoul National University Bundang Hospital, selected to lead the study. It will involve participants aged 50 years and above diagnosed with angiogenesis-dependent macular degeneration.Researchers are hoping to complete trials by February 2020.While ranibizumab, the formula for Lucentis, has been proven to be effective the prohibitive cost of the drug has had an impact on patient compliance.Currently, patients are charged as much as US$895 (AU$1,188) per 3mg vial of the sight-saving drug, which often requires patients to undergo monthly injections for it to be effective.However, with ranibizumab scheduled to go ‘off patent’ by 2020 in Europe and 2022 in the US, pharmaceutical companies are scrambling to develop an alternative.Other Korean biotech firms such as Bio CND and Biocure Pharm are also racing to develop a biosimilar version of Lucentis, but German developer of biosimilar agents, Formycon, has already launched phase III trials and appears to be leading the charge.
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