Samsung Bioepis Announces New Biosimilar Partnership, Regulatory Updates

Samsung Bioepis provided multiple updates on its biosimilar projects, including a new partnership for its aflibercept biosimilar candidate as well as regulatory news in the European Union and Republic of Korea.

Partnership With Samil Pharmaceutical and an Approval

Samsung Bioepis has partnered with Samil Pharmaceutical to bring SB15, an aflibercept biosimilar, to the Korean market, according to a report from Korea Biomedical Review.

SB15 references Eylea, an anti–vascular endothelial growth factor agent used to treat ophthalmic conditions, such as diabetic macular edema and wet age-related macular degeneration. Eylea accumulated $9.7 billion globally in 2023.

The new partnership for SB15 marks the second in the ophthalmology space. In June 2022, the companies agreed on a marketing partnership concerning Amelivu, a ranibizumab product that has been on the Korean market since January 2023.

"Through this agreement, we will further enhance the synergy between our R&D [research and development] capabilities and Samil Pharmaceutical's sales and marketing expertise," Samsung Bioepis CEO Han-sung Ko said. "We will strive to provide more domestic patients with ophthalmic diseases with treatment opportunities through high-quality biopharmaceuticals."

Shortly after the partnership was announced, SB15 (Aflilivu) received approval from the Republic of Korea’s Ministry of Food and Drug Safety. Samsung Bioepis is the first company to have obtained approval for both a ranibizumab biosimilar and an aflibercept biosimilar in the Republic of Korea.

CHMP Positive Opinion for Ustekinumab Biosimilar

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for approval for SB17 (Pyzchiva), Samsung Bioepis’ ustekinumab biosimilar candidate. If the product is granted marketing authorization by the European Commission, SB17 would be the second ustekinumab biosimilar approved for the region.

Ustekinumab is a human IgG1κ monoclonal antibody that inhibits IL-12 and IL-23. The committee granted the positive opinion for Pyzchiva to be used in the treatment of plaque psoriasis, Crohn disease, ulcerative colitis, pediatric plaque psoriasis, and psoriatic arthritis.

When the biosimilar enters the European market, Sandoz will be responsible for commercialization of Pyzchiva throughout the region as well as the US, Canada, the European Economic Area, Switzerland, and the United Kingdom.