South Korea’s Samsung Bioepis Co. will develop a biosimilar version of Lucentis to treat age-related macular degeneration (AMD), throwing down the gauntlet to Roche, a Swedish pharmaceutical company that generates $3.8 billion a year from the blockbuster drug alone.

AMD is one of the most common causes of vision loss in developed countries.

Samsung Bioepis has recently posted a plan for a phase III study of SB11, its biosimilar version of Lucentis (ranibizumab), according to ClinicalTrials.gov, the NLM-developed web-based registry and results database of clinical research studies, on Sunday. Under the plan, Samsung Bioepis will initiate the trial from September of this year, which will be led by Dr. Woo Se-jun, an ophthalmologist at Seoul National University Bundang Hospital. The study involving patients aged 50 years or older with angiogenesis-dependent macular degeneration will compare the biosimilar and the reference biologic drug. If done successfully, the clinical trial would be completed sometime in February 2020.

Lucentis co-developed by Roche’s subsidiary Genentech and Novartis is directly injected into the eye to protect patients against macular degeneration.

AMD exacts a major burden on patients because of limited access to available treatment options and expensive costs that are 1 million won ($895) for one vial (3 mg). A patient with diabetic macular edema who administers Luncentis 0.5 mg for 20 weeks has to pay more than 3 million won a month.

Ranibizumab, the active ingredient of Lucentis, will become off patent in 2020 in Europe and in 2022 in the U.S. According to IMS Health data, Lucentis generated $3.8 billion in global sales in 2015. In Korea, biotech firms like Bio CND and Biocure Pharm are racing to develop a biosimilar version of Lucentis.

By Kim Yoon-jin

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