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Amgen starts phase III trial for aflibercept biosimilar Posted 13/03/2020

US-based biotech giant Amgen is initiating a phase III clinical trial for a biosimilar of Regeneron’s Eylea (aflibercept).

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor. It is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy in patients with diabetic macular oedema.

Amgen’s trial is a randomized, double-masked, 4-arm, phase III study of their candidate aflibercept biosimilar, ABP 938, versus Eylea. It will compare the efficacy and safety of the two products in subjects with neovascular age-related macular degeneration.

Amgen plans to enrol 566 participants at approximately 116 global sites. Subjects will be randomized in a masked 1:1 ratio to receive 2 mg (0.05 mL) of either ABP 938 (Treatment Group A) or Eylea (Treatment Group B) administered by intravitreal (IVT) injection.

The primary endpoint is the change in Best Corrected Visual Acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score from baseline to Week 8. Secondary endpoints include change from baseline in BCVA, change from baseline in ETDRS letter score at Week 8 and Week 52, change from baseline in Choroidal Neovascularization (CNV) area, change from baseline in Central Subfield Thickness (CST) and number of subjects with incidence of anti-drug antibodies (ADA).

The study will last for a total of 56 weeks for each subject and is expected to be completed in April 2022.

Amgen is not the only one pursuing an aflibercept biosmilar. South Korean biologicals company Alteogen started a phase I trial for its candidate aflibercept biosimilar ALT-L9 in 2019 [1]. Momenta, who is developing an aflibercept biosimilar candidate, M710, with Mylan, is carrying out a ‘pivotal clinical trial’ and ‘expects to target US jointly developing an aflibercept biosimilar, FYB203 [2]. US-based Coherus BioSciences is expected to initiate phase III clinical trials for its aflibercept biosimilar candidate, CHS-2020, in 2021 with launch projected in 2025.

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Alteogen gains approval to start aflibercept biosimilar trial in Korea

Alteogen wins process patent for aflibercept biosimilar

References
1. GaBI Online - Generics and Biosimilars Initiative. Phase I trials started for aflibercept and ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 13]. Available from: www.gabionline.net/Biosimilars/News/Phase-I-trials-started-for-aflibercept-and-ustekinumab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Mylan/Momenta announce development strategy for aflibercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 13]. Available from: www.gabionline.net/Biosimilars/General/Mylan-Momenta-announce-development-strategy-for-aflibercept-biosimilar

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Source: clinicaltrials.gov

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