Aflibercept Biosimilars Gain EU Approval, Biosimilars Canada Launches Employer Campaign, and Celltrion Shares Positive Biosimilar Data
核心洞察
The European Commission (EC) has granted marketing authorization to aflibercept biosimilars developed by Sandoz (Afqlir) and Samsung Bioepis (搜索)/Biogen (Opuviz) for treating retinal conditions like neovascular age-related macular degeneration (搜索) (nAMD (搜索)).
Biosimilars Canada has initiated the #SaveBigWithBiosimilars campaign to encourage Canadian businesses to integrate biosimilar transition policies into employee health benefit plans, potentially reducing drug costs by 25% to 50%.
Celltrion presented Phase 3 data at the American College of Rheumatology Convergence 2024, demonstrating the biosimilarity of CT-P41 (denosumab biosimilar) and CT-P47 (tocilizumab biosimilar) to their reference products.
The European Commission (EC) has approved two aflibercept biosimilars, Afqlir from Sandoz and Opuviz (SB15) from Samsung Bioepis (搜索) and Biogen, marking a significant step toward more affordable treatment options for retinal conditions. Meanwhile, Biosimilars Canada is campaigning to promote biosimilar adoption among Canadian employers, and Celltrion has released positive Phase 3 data for its denosumab and tocilizumab biosimilars.
Aflibercept Biosimilars Approved in Europe
Sandoz's Afqlir and Samsung Bioepis (搜索)/Biogen's Opuviz have received marketing authorization from the EC. Afqlir is poised for launch in Q4 2025, offering a cost-effective alternative for conditions like neovascular age-related macular degeneration (搜索) (nAMD (搜索)). nAMD, while representing a minority of AMD cases (10-20%), accounts for a significant proportion (90%) of severe vision loss associated with AMD, impacting millions worldwide. These aflibercept products target vascular endothelial growth factor (VEGF (搜索)) and are used to treat various retinal conditions, including nAMD, diabetic retinopathy (搜索), retinal vein occlusion (搜索), and macular edema (搜索).
The approval of Afqlir was supported by comprehensive analytical, preclinical, and clinical data, confirming its equivalent efficacy and safety profile compared to the reference product, Eylea. Opuviz's approval was based on a Phase 3 randomized, double-masked study across 10 countries, which demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PK) to the reference aflibercept. Key outcomes included improvements in best-corrected visual acuity and central subfield thickness, with sustained efficacy observed through week 56 after switching from the originator to SB15.
Biosimilars Canada's Employer Campaign
Biosimilars Canada has launched the #SaveBigWithBiosimilars campaign to encourage Canadian businesses to adopt biosimilar transition policies within their employee health benefit plans. This initiative aims to bridge the gap between public and private drug programs in Canada, where biosimilar adoption lags in the private sector. The campaign provides resources such as an Employer Handbook on Biosimilars to guide companies in integrating cost-saving biosimilars, which can reduce drug costs by 25% to 50%.
Biologic medicines, while life-saving, constitute a substantial portion (36.4%) of private drug plan costs in 2023, despite accounting for only 3.9% of claims. Transitioning patients from original biologics to biosimilars can yield significant savings, enabling employers to sustain drug plans, expand access to new therapies, and enhance health benefits. British Columbia's experience, with $732 million saved over 5 years through biosimilar switching, highlights the potential impact of widespread biosimilar adoption.
Celltrion's Biosimilar Data
Celltrion presented Phase 3 trial data for CT-P41 (denosumab biosimilar referencing Prolia/Xgeva) and CT-P47 (tocilizumab biosimilar referencing Actemra) at the American College of Rheumatology Convergence 2024. CT-P41 demonstrated comparable efficacy and safety to the reference product in postmenopausal women with osteoporosis (搜索) (PMO) over 78 weeks, including after a single transition from the reference product. A post-hoc analysis showed no significant clinical impact of antidrug antibodies (ADAs) on PK, efficacy, or safety, despite a higher ADA incidence compared with historical studies.
CT-P47 showed sustained efficacy, safety, and immunogenicity comparable to the reference product in patients with moderate to severe rheumatoid arthritis (搜索) (RA) over one year, even after a single transition. These results support CT-P41 and CT-P47 as viable treatment options, offering cost-effective alternatives while maintaining therapeutic equivalence to reference therapies.