Samsung Bioepis releases data on trastuzumab and ranibizumab biosimilars

Biosimilars/Research | Posted 05/06/2020 post-comment0 Post your comment

Samsung Bioepis has released follow-up data for its approved trastuzumab biosimilar Ontruzant, as well as interim results for its proposed Lucentis (ranibizumab) biosimilar.

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Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers. It has been marketed by Genentech as Herceptin, with costs in the region of US$70,000 for one course of treatment.

Samsung Bioepis’ Ontruzant was the first trastuzumab biosimilar approved in Europe in November 2017. It was later approved by the US Food and Drug Administration in January 2019 [1].

The company has now released data on four-year event-free survival (EFS) and overall survival (OS) rates for Ontruzant. The data were presented at the ASCO20 Virtual Scientific Program (29‒31 May 2020) and followed-up from the three-year follow-up data presented at the 2019 International Maternal Cancer Congress [2].

The data were from 367 patients with a median follow-up of 53 months. The results showed that EFS (83.4% vs 80.7%) and OS (94.4% vs 89.6%) rates were comparable between Ontruzant and the reference trastuzumab.

Cardiac safety, which is one of the most serious risks from taking trastuzumab, was also comparable between the two products. There were no occurrences of symptomatic congestive heart failure.

Seongwon Han, Vice President, Medical & Lifecycle Safety Lead at Samsung Bioepis, said the follow-up results support the comparable safety and efficacy profiles of Ontruzant and reference trastuzumab.

‘We hope these findings on long-term safety and efficacy help build confidence in the use of biosimilars for prescribers and patients,’ he added.

The company have also announced results from a phase III trial of its ranibizumab biosimilar.

Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. Ranibizumab inhibits angiogenesis (the formation of new blood vessels) by inhibiting vascular endothelial growth factor A (VEGF-A), a mechanism similar to bevacizumab [3].

Samsung Bioepis has been developing a biosimilar version of ranibizumab and expanded its agreement with Biogen to include it late 2019 [4].

The phase III study of ranibizumab biosimilar, SB11, met its primary endpoints and showed equivalent efficacy to Lucentis, in terms of change in best-corrected visual acuity (BCVA) at Week 8 and central subfield thickness (CST) at Week 4.

The incidence of adverse events was also very similar (66% vs 66.9%) between the biosimilar and reference product, as was the level of anti-drug antibodies and pharmacokinetic serum concentrations.

The data were due to be presented at Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, which has been cancelled due to the COVID-19 pandemic.

‘We are excited to share this news on the development of our first treatment for ophthalmic diseases,’ said Seongwon Han. ‘These 24-week interim results suggest that SB11 will be a valuable treatment option for nAMD, potentially helping millions of patients worldwide.’

The company will however face competition. Canadian firm Bausch + Lomb, for example, recently signed an agreement with Stada and Xbrane to develop and commercialize the Lucentis biosimilar Xlucane in Canada and the US [5].

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Samsung Bioepis and AffaMed to start trastuzumab trial in China

Biosimilars of ranibizumab

1. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Ontruzant []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 5]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Comparability of biosimilar Ontruzant maintained over three years []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 5]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 5]. Available from:
4. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis expands biosimilars agreement with Biogen []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 5]. Available from:
5. GaBI Online - Generics and Biosimilars Initiative. Canadian firm Bausch + Lomb signs agreement on Lucentis biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 5]. Available from:

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