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Drug developer hits major milestone with Lucentis biosimilar

A biopharmaceutical company that is developing cheaper anti-VEGF treatments for major global markets, including Australia, has reported positive results from a Phase 3 clinical trial for its Lucentis biosimilar.

Korean-based Samsung Bioepis has announced that it has met the primary end points in a randomised, double-masked, trial assessing the efficacy, safety and immunogenicity of SB11, a ranibizumab (Lucentis) biosimilar candidate, for neovascular age-related macular degeneration (nAMD).

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

The results add momentum to the company’s efforts to develop and commercialise two ophthalmology biosimilar candidates, SB11 (ranibizumab/Lucentis) and SB15 (aflibercept/Eylea), in the US, Canada, Europe, Japan, and Australia.

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 alone, it has been estimated that savings generated from biosimilar uptake could reach as high as US$150 billion (AU$217 b) over a 10-year period.

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

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

Further comparing the SB11 and Lucentis, the trial found the least squares (LS) mean change in BCVA was 6.2 letters for SB11, compared with 7.0 letters for the reference drug Lucentis.

The LS mean change in CST was −108.4μm for SB11 versus −100.1μm for Lucentis. The confidence interval (CI) of the difference between the two treatments in BCVA and CST was within the predefined equivalence margins.

The incidence of treatment-emergent adverse events was 66% for SB11 and 66.9% for Lucentis. The overall incidence of anti-drug antibodies was low (3.0% for SB11 vs 3.1% for Lucentis). Pharmacokinetic serum concentrations also appeared comparable.

In November, Samsung Bioepis announced a new commercialisation agreement with US firm Biogen in a deal worth up to US$310 million (AU$453 m) to supply the biosimilar therapies for major markets, including Australia.

Samsung Bioepis is a joint venture that was established between Samsung BioLogics and Biogen in 2012. It has pipeline of biosimilar candidates for immunology, oncology, ophthalmology and hematology.