Samsung Bioepis received marketing approval for Amelivu Inj. (ranibizumab), a biosimilar referencing Lucentis to treat various eye diseases in Korea.

However, the local market release of the treatment will take some time due to a patent-related agreement between Samsung Bioepis and Genentech, the developer of the original drug, Lucentis.

On Monday, the Ministry of Food and Drug Safety said that it authorized Samsung Bioepis’ Amelivu on Friday.

The licensed indications of Amelivu include neovascular (wet) age-related macular degeneration (AMD), visual impairment caused by diabetic macular edema, proliferative diabetic retinopathy, and visual impairment due to central retinal vein occlusion macular edema, and visual impairment due to myopic choroidal neovascularization.

Lucentis is an eye disease treatment developed by Genentech and sold by Roche and Novartis. In 2020, its global sales reached about 4 trillion won ($3.11 billion).

With the latest nod, Samsung Bioepis can expect to raise sales from the prescriptions of the Lucentis biosimilar not only in the U.S. but in Korea.

Earlier in September, Samsung Bioepis obtained the U.S. FDA approval for the Lucentis biosimilar (brand name: Byooviz)

However, it will take some time to release Amelivu in Korea because Samsung Bioepis has to comply with the patent-related agreement clinched with Genentech.

Samsung Bioepis inked a licensing deal with Genentech last year to resolve Lucentis patient issues.

Under the deal, Samsung Bioepis can sell the biosimilar as of June 2022 before the expiration of Genentech’s supplementary protection certificate (SPC). Samsung Bioepis can market the product in other regions after Genentech’s SPC expires.

SPC extends the patent protection period lost due to the time required for procedures such as drug approval. When Genentech’s SPC for Lucentis expires remains undisclosed.

Samsung Bioepis has yet to choose a local sales partner for Amelivu.

The company usually distributes its biosimilar products through cooperation with Korean drug companies in the local market.

It sells autoimmune disease treatment Adalloce, a Humira biosimilar, jointly with Yuhan Corp., and anti-cancer biosimilars Samfenet and Onbevzi with Boryung Pharmaceutical.

“With the approval for Amelivu, we can expand our business area to ophthalmic diseases. We will continue to provide various treatment opportunities to Korean patients through our biosimilar products,” an official at Samsung Bioepis said.