Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data

The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.

EU Aflibercept Approvals

Sandoz announced that the European Commission (EC) approved Afqlir, planning to launch the product in the fourth quarter of 2025.¹ Afqlir offers an affordable treatment option for conditions like neovascular age-related macular degeneration (nAMD), which is a leading cause of severe vision loss in individuals older than 65 years. Although nAMD accounts for only 10% to 20% of all AMD cases, it is responsible for 90% of the severe vision loss associated with AMD, affecting millions globally.

Aflibercept products referencing Eylea are anti–vascular endothelial growth factor receptor agents used to treat retinal conditions, including nAMD, diabetic retinopathy, retinal vein occlusion, and macular edema.

The approval was backed by robust analytical, preclinical, and clinical data, confirming its equivalent efficacy and safety compared with its reference product.

Additionally, Samsung Bioepis and Biogen announced EC approval for Opuviz (SB15), another aflibercept biosimilar. The approval marked the second ophthalmology biosimilar approved under their partnership.²

The approval was based on robust evidence, including a phase 3 randomized, double-masked study conducted across 10 countries. The study demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PKs) between SB15 and reference aflibercept. Key outcomes included improvements in best corrected visual acuity and central subfield thickness, as well as sustained efficacy through week 56 after rerandomization and switching from the originator to SB15.

This milestone highlights Samsung Bioepis and Biogen’s commitment to improving access to affordable, high-quality biologic treatments. Opuviz represents the fifth biosimilar in their European portfolio, supporting cost-effective care and health care system sustainability.

Biosimilars Canada Launches Employer Campaign

Biosimilars Canada has launched the #SaveBigWithBiosimilars campaign to educate Canadian businesses on incorporating biosimilar transition policies into employee health benefit plans.³ Although public drug programs in Canada have widely adopted such policies, the private market lags behind.

The campaign includes a downloadable Employer Handbook on Biosimilars to guide companies on integrating cost-saving biosimilars, which can reduce drug costs by 25% to 50%. Biologic medicines, although lifesaving, are costly, making up 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 generate significant savings, enabling employers to:

• Sustain drug plans and expand access to new therapies
• Enhance health benefits, offering perks like vision care and massage coverage
• Improve competitiveness in attracting and retaining employees

Examples like British Columbia’s $732 million savings over 5 years showcase the potential impact of biosimilar adoption.

Although private insurance plans increasingly offer biosimilar transition programs, they remain underutilized, with private biosimilar use trailing public programs by 30%. Expanding biosimilar adoption can help businesses manage rising costs and improve employee benefits sustainably.

Celltrion Shares Denosumab, Tocilizumab Data

Celltrion presented promising phase 3 trial data for 2 biosimilar candidates at the American College of Rheumatology Convergence 2024.⁴ CT-P41, a denosumab biosimilar referencing Prolia/Xgeva, demonstrated comparable efficacy and safety to the reference product in postmenopausal women with osteoporosis (PMO) over 78 weeks, including after a single transition from the reference product. A post-hoc analysis revealed no significant clinical impact of antidrug antibodies (ADAs) on PKs, efficacy, or safety, despite a higher ADA incidence compared with historical studies. These findings confirm the biosimilarity of CT-P41 and support its therapeutic potential for treating PMO.

Similarly, CT-P47, a tocilizumab biosimilar referencing Actemra, showed sustained efficacy, safety, and immunogenicity comparable to the reference product in patients with moderate to severe rheumatoid arthritis (RA) over 1 year, even after a single transition. Experts emphasized the value of biosimilars in reducing health care costs and improving patient access while maintaining therapeutic equivalence to reference therapies. These results further establish CT-P41 and CT-P47 as viable treatment options in their respective indications.

References

1. Sandoz receives European Commission approval for Afqlir (aflibercept), further strengthening leading biosimilar portfolio. Press release. Sandoz. November 15, 2024. Accessed November 19, 2024. https://finance.yahoo.com/news/sandoz-receives-european-commission-approval-060000286.html?guccounter=1

2. Samsung Bioepis and Biogen receive European Commission (EC) approval for aflibercept biosimilar, Opuviz. Press release. Samsung Bioepis. November 18, 2024. Accessed November 19, 2024. https://www.globenewswire.com/news-release/2024/11/18/2982600/0/en/Samsung-Bioepis-and-Biogen-Receive-European-Commission-EC-Approval-for-Aflibercept-Biosimilar-OPUVIZ.html

3. #SaveBigWithBiosimilars campaign provides sustainable solutions for employer-sponsored health benefit plans. Press release. Biosimilars Canada. November 14, 2024. Accessed November 19, 2024. https://biosimilarscanada.ca/blog/savebigwithbiosimilars-campaign-provides-sustainable-solutions-for-employer-sponsored-health-benefit-plans/

4. Celltrion presents additional data from phase III randomized controlled trials to further support biosimilarity for CT-41 (biosimilar candidate of denosumab) and CT-P47 (biosimilar candidate of tocilizumab) at American College of Rheumatology (ACR) Convergence 2024. Press release. Celltrion. November 18, 2024. Accessed November 19, 2024. https://www.prnewswire.com/news-releases/celltrion-presents-additional-data-from-phase-iii-randomized-controlled-trials-to-further-support-biosimilarity-for-ct-41-biosimilar-candidate-of-denosumab-and-ct-p47-biosimilar-candidate-of-tocilizumab-at-american-college-of--302308791.html