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Eylea biosimilar embarks on Phase 3 trial

A biopharmaceutical company that is developing cheaper anti-VEGF treatments for Australia and other markets has launched a global clinical trial for a biosimilar version of leading treatment Eylea (aflibercept).

Korean-based Samsung Bioepis has announced the Phase 3 clinical trial of SB15 will take place in eight countries, including South Korea. It is is a randomised, double-masked, parallel group, multicentre study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB15 and Eylea in 446 patients with neovascular age-related macular degeneration.

According to industry sources, Korea’s health authorities gave Samsung Bioepis the go-ahead for a trial of SB15 following FDA approval for the trial in the US.

Ultimately, the company intends to commercialise its own cheaper versions of the macular disease treatments in major global markets, including the US, Canada, Europe, Japan and Australia.

It follows the company’s recent completion of a Phase 3 study of SB11, a biosimilar of Lucentis (ranibizumab), another commonly prescribed age-related macular degeneration (AMD) therapy.

Compared with Lucentis, which was used as the reference drug, SB11 demonstrated equivalent efficacy in terms of change in best corrected visual activity at week eight and central subfield thickness at week four.

Samsung Bioepis is now preparing to file a regulatory application seeking marketing approval for SB11.

It is aiming to capitalise on the expiration of patents for Lucentis and Eylea – both listed on the Australian Pharmaceutical Benefits Scheme – in the coming years and offer a cheaper alternative for health systems and patients in the US, Canada, Europe, Japan, and Australia.

If successfully commercialised, SB11 and SB15 would be the first biosimilar versions of Lucentis (ranibizumab) and Eylea, arguably two of the most commonly prescribed AMD drugs on the market.

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