The buzz on biosimilars: News in November 2024
With news of several biosimilar candidates moving along the path of approval, Modern Retina is taking a moment to recap the updates on the state of these biosimilars.
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Biosimilar candidates have been making headlines in November 2024. Several biosimilars are moving along the path to approval, meaning that more potential treatment options may soon be available to patients in Europe.
Notably all 3 of the candidates in the news have been aflibercept biosimilars indicated for the treatment of age-related macular degeneration (AMD). In this articles, Modern Retina will highlight the status of these candidates and.
Samsung Bioepis
The European Commission (EC) has approved OPUVIZ 40 mg/mL solution for injection in a vial. OPUVIZ is a biosimilar referencing Eylea (aflibercept). The biosimilar has been developed and registered by Samsung Bioepis.1
The biosimilar now known by the brand name OPUVIZ was previously known as the biosimilar candidate SB15. It has been approved for use in adult patients for the treatment of neovascular AMD, visual impairment due to macular edema secondary to retinal vein occlusion (RVO; branch or central RVO), visual impairment due to diabetic macular edema (DME), and visual impairment due to myopic choroidal neovascularization (myopic CNV).1
Read more about the EC approval of SB15.
Sandoz Group
The EC granted marketing authorization for Afqlir (aflibercept), which is a 2 mg vial kit and pre-filled syringe for intravitreal injection. This is a biosimilar to reference aflibercept. The biosimilar is indicated to treat retinal diseases, including neovascular AMD.2
In August of 2024, Sandoz announced it has received FDA approval for aflibercept-abzv (Enzeevu) 2 mg vial kit and pre-filled syringe for intravitreal injection.3
Read more about the marketing authorization of Afqlir.
Formycon AG and Klinge Biopharma GmbH
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of FYB203, a biosimilar candidate to aflibercept. FYB203 was approved by the US Food and Drug Administration (FDA) in June 2024.4
Read more about the of FYB203 marketing authorization.
Reference:
Samsung Bioepis and Biogen Receive European Commission (EC) Approval for Aflibercept Biosimilar, OPUVIZ™. Samsung Bioepis Co., Ltd. November 18, 2024. Accessed November 18, 2024. https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=424¤tPage=1
Sandoz receives European Commission approval for Afqlir® (aflibercept), further strengthening leading biosimilar portfolio. Sandoz Group. November 15, 2024. Accessed November 15, 2024. https://www.globenewswire.com/news-release/2024/11/15/2981760/0/en/Sandoz-receives-European-Commission-approval-for-Afqlir-aflibercept-further-strengthening-leading-biosimilar-portfolio.html
Sandoz.com. Published 2024. Accessed August 12, 2024. https://www.sandoz.com/sandoz-receives-fda-approval-enzeevutm-aflibercept-abzv-further-strengthening-us-biosimilar/
Formycon receives positive CHMP opinion for FYB203 (aflibercept), a biosimilar candidate to Eylea® under the tradenames AHZANTIVE® and Baiama®. Formycon AG. November 18, 2024. Accessed November 18, 2024. https://www.eqs-news.com/news/corporate/formycon-receives-positive-chmp-opinion-for-fyb203-aflibercept-a-biosimilar-candidate-to-eylea-under-the-tradenames-ahzantive-and-baiama/2168417
