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Samsung Bioepis Reports Equivalency for Ranibizumab Biosimilar


After completing a 24-week phase 3 trial, Samsung Bioepis said its biosimilar ranibizumab (SB11) has demonstrated clinical equivalence to reference Lucentis for the treatment of neovascular age-related macular degeneration.

South Korea-based Samsung Bioepis announced that its ranibizumab biosimilar (SB11) demonstrated equivalent efficacy, safety, and immunogenicity to the reference product (Lucentis) in a 24-week phase 3 clinical trial involving patients with neovascular age-related macular degeneration (nAMD).

“We are excited to share this news on the development of our first treatment for ophthalmic diseases,” said Seong Won Han, medical team leader at Samsung Bioepis, in a statement.

Investigators evaluated the improvement in best corrected visual activity, a measurement of vision impairment, at week 8, finding the least squares (LS) mean change for SB11 to be 6.2 versus 7.0 letters for reference ranibizumab (90% CI), which was within the predefined margin of ± 3 letters.

Change in Subfield Thickness

At week 4, the LS mean change for central subfield thickness (CST), the depth of the small curve in the retina where vision is most acute, was also analyzed. The CST change for SB11 was —108.4 μm, which was comparable to reference ranibizumab with a CST change of –100.1 μm (95% CI), and well within the predefined margin of ± 36 μm.

The incidence of drug-related adverse events was 66% for SB11 and 66.9% for reference ranibizumab. Antidrug antibody formation was also low, with a 3.0% incidence for SB11 versus 3.1% for the reference product. In addition, pharmacokinetic serum concentrations were found to be comparable.

“These 24-week interim results suggest that SB11 will be a valuable treatment option for nAMD, potentially helping millions of patients worldwide,” said Seong.

Samsung Bioepis planned to present the data at the Association for Research in Vision and Ophthalmology Annual Meeting 2020; however, the meeting was cancelled due to the coronavirus disease 2019 (COVID-19) pandemic.

nAMD is a form of age-related macular degeneration (AMD), which is the leading cause of blindness in people over the age of 60. It is more severe than AMD and is characterized by the formation of new and abnormal blood vessels, with uncontrolled growth under the retina, causing swelling, bleeding, and fibrosis.

Recently, Samsung Bioepis also announced clinical trial data for its trastuzumab biosimilar (Ontruzant) that demonstrate equivalency to the reference product, Herceptin, in various settings. Ontruzant was launched on the US market in April 2020.

Additionally, the company announced in November 2019 that it entered into an agreement with Biogen for SB11 as well as SB15, an aflibercept biosimilar referencing Eylea, for commercialization in the United States, Canada, Europe, Japan, and Australia.

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