Chong Kun Dang Pharmaceutical said Thursday it received approval for LucenBS (ingredient: ranibizumab), a biosimilar referencing Lucentis to treat wet age-related macular degeneration (AMD), from the Ministry of Food and Drug Safety.

LucenBS has secured all five indications of Lucentis -- neovascular wet AMD, visual impairment caused by diabetic macular edema, proliferative diabetic retinopathy, visual impairment caused by retinal vein occlusive macular edema, and visual impairment caused by the formation of new blood vessels in the choroid.

The company began developing its biosimilar in 2012 and entered phase 3 clinical trials in 25 hospitals, including Seoul National University Hospital, targeting 312 patients with wet AMD in 2018. The company completed the phase 3 clinical trial in April 2021.

As a result of the trial, Chong Kun Dang confirmed that the biosimilar’s efficacy and other pharmacokinetics, immunogenicity, and safety were all clinically equivalent to those of the original drug, and applied for product approval in July 2021.

“LucenBS is a high-purity biosimilar product developed by Chong Kun Dang with its own proprietary technology and secured all indications of the original drug,” a company official said. “We will expand market share globally by targeting the Korean market worth about 32 billion won ($22.3 million) and Southeast Asia and the Middle East worth about 200 billion won.”

Chong Kun Dang is the second company to launch a Lucentis biosimilar in Korea after Samsung Bioepis.

Samsung Bioepis received approval for Amelivu, its Lucentis biosimilar, in May.

In June, Samsung Bioepis chose Samil Pharmaceutical, a strong player in eye disease treatments, as its partner to market Amelivu in Korea.

Samil and Chong Kun Dang will likely compete for Lucentis biosimilar sales in Korea, observers said.