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Samsung Bioepis Begins Phase 3 Trial for Aflibercept Biosimilar


A phase 3 clinical trial comparing the safety, efficacy, and immunogenicity of Samsung Bioepis’ aflibercept biosimilar with reference Eylea is now underway.

Incheon, Republic of Korea—based company Samsung Bioepis has initiated a phase 3 clinical trial for it aflibercept biosimilar candidate, SB15.

The randomized, double-masked, parallel group, multicenter study will compare SB15 and reference Eylea on safety, efficacy, pharmacokinetics, and immunogenicity.

The comparison test will enroll 446 patients with neovascular age-related macular degeneration (wet AMD), an eye disease caused by abnormal blood vessels leaking fluid or blood into the macula of the eye, leading to blurred vision or a blind spot in the vision field, according to Mayo Clinic.

SB15 is included in a commercialization agreement between Samsung Bioepis and Biogen that was established in 2019. The deal also includes the commercialization rights for Samsung Bioepis’ ranibizumab biosimilar and covers the marketing rights for the 2 products for the United States, Canada, Europe, Japan, and Australia.

Clinical Trial Details

In the SB15 trial, the 2 treatment arms will randomize participants to a biosimilar or a reference group. Patients will receive an intravitreal injection of 2 mg (0.05 ml) of their respective drug once every 4 weeks. After 3 months, they will receive the same dosage once every 8 weeks.

After week 32, participants in the Eylea group will be rerandomized into 2 groups: switch to SB15 and stay on Eylea. They will continue to receive the same dose once every 8 weeks until week 48. A final assessment will be conducted at week 56.

Currently, participants are being recruited from the United States, Estonia, Hungary, Latvia, and Poland, with more locations to be added. .

Samsung Bioepis Pipeline

Last week, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended Samsung Bioepis’ bevacizumab biosimilar (Aybintio) for approval.

Samsung Bioepis currently has 4 biosimilars approved in Europe, the United States, Australia, and the Republic of Korea: etanercept (Eticovo), infliximab (Renflexis), adalimumab (Hadlima), and trastuzumab (Ontruzant).

In 2019, Ontruzant became the first biosimilar to be prequalified by the World Health Organization, which has the potential to help guide many low- and middle-income countries in selecting medicines, promoting the use of the biosimilar, and lowering prices of trastuzumab.

Samsung Bioepis is also developing 4 other biosimilars, with Aybintio being the furthest along and the only one in the filing stage.

Ranibizumab (SB11) has completed a phase 3 trial and another 1 is currently underway for an eculizumab (SB12) biosimilar.

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