Aflibercept Biosimilars Gain Momentum in Europe with Multiple Approvals and Positive Opinions
核心洞察
The European Medicines Agency's CHMP recommended Amgen's Pavblu and Skojoy (搜索), aflibercept biosimilars, for approval in January 2025, expanding treatment options for retinal diseases.
Sandoz's Afqlir (aflibercept) received marketing authorization from the European Commission, offering an affordable alternative for conditions like neovascular AMD (搜索), expected to launch in Q4 2025.
Several aflibercept biosimilars, including Samsung Bioepis (搜索)' OPUVIZ and Formycon's FYB203, have recently been approved or received positive opinions, increasing patient access to AMD (搜索) treatments.
The European landscape for treating retinal diseases is rapidly evolving with the increasing availability of aflibercept biosimilars. Several companies have recently achieved significant milestones in gaining approval and positive opinions for their biosimilar candidates, promising to broaden patient access to these therapies.
CHMP Recommends Amgen's Aflibercept Biosimilars
In January 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of two aflibercept biosimilars, Pavblu and Skojoy (搜索), manufactured by Amgen. These biosimilars are indicated for the treatment of neovascular (wet) age-related macular degeneration (搜索) (AMD (搜索)), visual impairment due to macular edema (搜索) secondary to retinal vein occlusion (搜索) (RVO (搜索)), and visual impairment due to myopic choroidal neovascularisation (搜索) (myopic CNV (搜索)). Pavblu also received a positive opinion for treating visual impairment due to diabetic macular edema (搜索) (DME (搜索)).
The CHMP's decision was based on data demonstrating comparable quality, safety, and efficacy to the reference product, Eylea (aflibercept), developed by Bayer AG and Regeneron. Pavblu and Skojoy (搜索) will be available as a 40 mg/ml solution for injection, offered in both pre-filled syringes and vials. With the CHMP's positive opinion on January 30, the European Commission is expected to make a final decision on marketing authorization.
European Commission Approves Sandoz's Afqlir
The European Commission granted marketing authorization for Afqlir (aflibercept), a biosimilar developed by Sandoz Group. Afqlir is available as a 2 mg vial kit and pre-filled syringe for intravitreal injection and is indicated for treating retinal diseases, including neovascular AMD (搜索). Sandoz anticipates launching Afqlir in Q4 2025.
Claire D’Abreu-Hayling, Chief Scientific Officer for Sandoz, emphasized the importance of this approval, stating, "Vision loss significantly affects daily activities, from work to social interactions. Early and expanded access to effective treatments is essential for patients to maintain and improve their visual acuity. The approval of Afqlir is a pivotal moment in delivering an affordable and effective treatment option to patients in Europe who are affected by conditions such as nAMD."
Other Aflibercept Biosimilars on the Horizon
Several other aflibercept biosimilars have also made significant progress in the European market. In November 2024, the European Commission approved OPUVIZ, an aflibercept biosimilar from Samsung Bioepis (搜索), for the treatment of neovascular AMD (搜索), visual impairment due to macular edema (搜索) secondary to RVO (搜索), visual impairment due to DME (搜索), and visual impairment due to myopic CNV (搜索). Additionally, the CHMP issued a positive opinion for FYB203, an aflibercept biosimilar candidate from Formycon AG and Klinge Biopharma GmbH (搜索).
The increasing availability of aflibercept biosimilars is expected to drive down treatment costs and improve patient access to these essential therapies for retinal diseases.