Biosimilar SB15 versus reference aflibercept in neovascular age-related macular degeneration: 1-year and switching results of a phase 3 clinical trial

. 2023 Dec 19 ; 8 (1) : . [epub] 20231219

Jazyk angličtina Země Anglie, Velká Británie Médium electronic

Typ dokumentu klinické zkoušky, fáze III, časopisecké články, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/pmid38114333

BACKGROUND/AIMS: To evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of SB15 versus reference aflibercept (AFL), and switching from AFL to SB15 in neovascular age-related macular degeneration (nAMD). DESIGN: Prospective, double-masked, randomised, phase 3 trial. METHODS: Participants with nAMD were randomised 1:1 to receive SB15 (N=224 participants) or AFL (N=225). At week 32, participants either continued on SB15 (SB15/SB15, N=219) or AFL (AFL/AFL, N=108), or switched from AFL to SB15 (AFL/SB15, N=111). This manuscript reports 1-year and switching results of secondary efficacy endpoints such as changes from baseline to week 56 in best-corrected visual acuity (BCVA), central subfield thickness (CST, from internal limiting membrane (ILM) to retinal pigment epithelium), and total retinal thickness (TRT, from ILM to Bruch's membrane). Additional endpoints included safety, PK and immunogenicity. RESULTS: Efficacy results were comparable between groups. The least squares mean (LSmean) change in BCVA from baseline to week 56 was 7.4 letters for SB15/SB15 and 7.0 letters for AFL/AFL (difference (95% CI)=0.4 (-2.5 to 3.2)). The LSmean changes from baseline to week 56 in CST and TRT were -119.2 µm and -132.4 µm for SB15/SB15 and -126.6 µm and -136.3 µm for AFL/AFL, respectively (CST: difference (95% CI)=7.4 µm (-6.11 to 20.96); TRT: difference (95% CI)=3.9 µm (-18.35 to 26.10)). Switched and non-switched participants showed similar LSmean changes in BCVA from baseline to week 56 (AFL/SB15, 7.9 letters vs AFL/AFL, 7.8 letters; difference (95% CI)=0.0 (-2.8 to 2.8)). Safety, PK and immunogenicity were comparable between groups. CONCLUSIONS: Efficacy, safety, PK and immunogenicity were comparable between SB15 and AFL and between switched and non-switched participants.

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FDA . Scientific considerations in demonstrating Biosimilarity to a reference product. Available: https://www.fda.gov/media/82647/download [Accessed 7 Mar 2023].

Hariprasad SM, Gale RP, Weng CY, et al. . An introduction to Biosimilars for the treatment of retinal diseases: a narrative review. Ophthalmol Ther 2022;11:959–82. 10.1007/s40123-022-00488-w PubMed DOI PMC

Sagong M, Lee H, Huh J, et al. . Analytical similarity assessment of an Aflibercept Biosimilar Sb15 to its commercially available reference product (Eylea). 2023 ARVO Annual Meeting 2023; (Abstract Number:); 2023.

Woo SJ, Bradvica M, Vajas A, et al. . Efficacy and safety of the Aflibercept Biosimilar Sb15 in Neovascular age-related macular degeneration: a phase 3 randomized clinical trial. JAMA Ophthalmol 2023;141:668–76. 10.1001/jamaophthalmol.2023.2260 PubMed DOI PMC

Allocati E, Godman B, Gobbi M, et al. . Switching among Biosimilars: a review of clinical evidence. Front Pharmacol 2022;13:917814. 10.3389/fphar.2022.917814 PubMed DOI PMC

Medicines for Europe . Positioning statements on physician-led switching for Biosimilar medicines. Available: https://www.medicinesforeurope.com/wp-content/uploads/2017/03/M-Biosimilars-Overview-of-positions-on-physician-led-switching.pdf [Accessed 7 Mar 2023].

Dugel PU, Koh A, Ogura Y, et al. . HAWK and HARRIER: phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology 2020;127:72–84. 10.1016/j.ophtha.2019.04.017 PubMed DOI

Heier JS, Brown DM, Chong V, et al. . Intravitreal Aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology 2012;119:2537–48. 10.1016/j.ophtha.2012.09.006 PubMed DOI

Heier JS, Khanani AM, Quezada Ruiz C, et al. . Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet 2022;399:729–40. 10.1016/S0140-6736(22)00010-1 PubMed DOI

EMA . Summary of product characteristics - Eylea. Available: https://www.ema.europa.eu/en/documents/product-information/eylea-epar-product-information_en.pdf [Accessed 7 Mar 2023].

Barbier L, Ebbers HC, Declerck P, et al. . The efficacy, safety, and Immunogenicity of switching between reference biopharmaceuticals and Biosimilars: a systematic review. Clin Pharmacol Ther 2020;108:734–55. 10.1002/cpt.1836 PubMed DOI PMC

EMA . Biosimilar medicines can be interchanged. Available: https://www.ema.europa.eu/en/news/biosimilar-medicines-can-be-interchanged#:~:text=EMA%20and%20the%20Heads%20of,or%20with%20an%20equivalent%20biosimilar [Accessed 7 Mar 2023].

Sharma A, Kumar N, Parachuri N, et al. . Biosimilar ranibizumab interchangeability: what does it mean to retinal physicians? Eye (Lond) 2023;37:1953–4. 10.1038/s41433-022-02287-w PubMed DOI PMC

EMA . Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1). Available: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-0.pdf [Accessed 7 Mar 2023].

EMA . Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Available: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active_en-2.pdf [Accessed 7 Mar 2023].

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