Samsung Bioepis has reported positive results from a phase III trial of its bevacizumab biosimilar, Aybinto. The company is also initiating a phase III trial for its aflibercept biosimilar, SB15.
Bevacizumab is a humanized monoclonal antibody treatment for a number of cancers, as well as age-related macular degeneration. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers including colorectal, lung, breast, glioblastoma, kidney and ovarian cancers. The originator product, Avastin, is sold by Roche/Genentech.
Samsung Bioepis has developed a biosimilar version of the drug sold under the trade name Aybintio, which was recommended for approval by the European Medicines Agency in June 2020 .
In August 2020, Samsung Bioepis announced that it had received European Commission approval for Aybintio, which allows the company to sell the drug on the European market.
Aybintio has been approved for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, epithelial ovarian, fallopian tube and primary peritoneal cancer and cervical cancer.
The approval was based on analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data, demonstrating clinical equivalence between reference bevacizumab and Aybintio.
The company has recently released data from a phase III study, which was presented at the European Society for Medical Oncology (ESMO) 2020 virtual congress.
The study compared Aybintio to reference bevacizumab in 665 patients with metastatic or recurrent non-squamous non-small cell lung cancer. Roughly half of the patients received Aybintio while the remainder received reference bevacizumab with paclitaxel and Q3W carboplatin up to six cycles, followed by Aybintio or reference bevacizumab maintenance monotherapy.
Risk difference in best overall response rate (ORR) and maximum percentage change from baseline in tumour burden were analysed at 11,17 and 24 weeks. The results confirmed the biosimilar’s clinical equivalence with the originator drug. For example, the mean reduction in tumour burden by Week 24 was –27.8% for Aybintio compared to –27.3% for the reference product.
Seongwon Han, Vice President and Team Lead of Medical & Lifecycle Safety Team at Samsung Bioepis commented: ‘The data observed in the Phase 3 exploratory analyses reinforce equivalent clinical efficacy between AYBINTIO and reference bevacizumab. We look forward to sharing our data to the medical community which further highlights our commitment and dedication towards delivering life-changing scientific research to make high quality biologic medicines’.
The company is also beginning a phase III trial for their proposed aflibercept biosimilar, which is currently known as SB15. Aflibercept (Eylea) can be used to treat colorectal cancer and macular degeneration and also targets VEGF.
The upcoming phase III study will compare efficacy, safety, pharmacokinetics and immunogenicity between SB15 and Eylea in 446 patients with neovascular age-related macular degeneration.
The randomized, multicentre trial will last 48 weeks, with a final assessment being conducted at Week 56. Participants are being recruited from Estonia, Hungary, Latvia, Poland and the US.
SB15 is included in a commercialization agreement between Samsung Bioepis and Biogen, which includes another ophthalmology drug, ranibizumab .
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1. GaBI Online - Generics and Biosimilars Initiative. EMA approves bevacizumab and teriparatide biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 25]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-bevacizumab-and-teriparatide-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis expands biosimilars agreement with Biogen [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 25]. Available from: www.gabionline.net/Pharma-News/Samsung-Bioepis-expands-biosimilars-agreement-with-Biogen
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