FDA Roundup: Eylea Biosimilars, Belimumab Autoinjector


Check out important updates from the FDA for the week of May 20.

FDA Approves Aflibercept (Eylea) Biosimilars, Yesafili and Opuviz

FDA Roundup: Eyela Biosimilars, Belimumab Autoinjector / grandbrothers - stock.adobe.com

FDA Roundup: Eylea Biosimilars, Belimumab Autoinjector / grandbrothers - stock.adobe.com

The FDA approved aflibercept-jbvf (Yesafili) and aflibercept-yszy (Opuviz), the first interchangeable biosimilars for aflibercept (Eylea). These medications are used to treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

The medications are vascular endothelial growth factor (VEGF) inhibitors, administered intravitreally as a 2 mg injectable solution. Anti-VEGF medications stop abnormal blood vessels from leaking, growing, and bleeding under the retina, which leads to pain and vision loss for patients.

FDA approval of both Yesafili and Opuviz were based on a “comprehensive review of scientific evidence demonstrating that each product is highly similar” to reference product aflibercept. Evidence included comparisons of each product to the reference product “on an analytical level, using an extensive and robust battery of physicochemical tests and biological assays” as well as a comparative clinical study in patients.

READ MORE: Study Reveals Robust Benefits of Semaglutide in Protecting Against Kidney, CV Events in Patients With T2D

FDA Approves Belimumab Autoinjector to Treat Systemic Lupus Erythematosus in Children

The FDA approved a 200 mg belimumab (Benlysta) autoinjector for children 5 years and older with systemic lupus erythematosus who are currently receiving standard therapy. Belimumab is a B-lymphocyte stimulator (BLyS)-specific inhibiting monoclonal antibody which was previously only available for that age group through an intravenous (IV) formulation.1

“Lupus tends to be more aggressive and affect children more severely than adults, with those diagnosed in childhood having higher rates of organ damage,” Mary T. Crimmings, Interim CEO and senior vice president for Marketing and Communications at the Lupus Foundation of America, said in a release.1 “Going to the doctor’s office once every four weeks can be a logistical hurdle for some children and their caregivers, so having the option to administer Benlysta in the comfort of their home provides much-needed flexibility.”

FDA Panel Backs Colorectal Cancer Screening Blood Test

The Molecular and Clinical Genetics Panel, which is part of the FDA’s Medical Devices Advisory Committee, “strongly recommended” a blood test for colorectal cancer screening from biotechnology company Guardant Health. The Shield blood test is for adults aged 45 and older who are at average risk for colorectal cancer.2

The advisory committee voted 8 to 1 favorably that there is reasonable assurance Shield is safe, 6 to 3 favorably that there is reasonable assurance Shield is effective, and 7 to 2 favorably that the benefits of Shield outweigh its risks. The panel’s recommendation will help the FDA decide whether or not to approve the test. Guardant said in the release that the FDA’s decision is expected later this year.

“The advisory committee’s strong support for the approval of Shield reinforces the crucial role that a blood test option can have in improving CRC screening rates for those at average risk,” Amir Ali Talasaz, co-CEO of Guardant Health, said in a release.2 “Despite the importance of detecting colorectal cancer early, there are notable barriers that can deter average-risk Americans from completing existing screening methods. Shield effectively detects cancer at an early stage when it is most treatable.”

READ MORE: FDA Updates Resource Center

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1. FDA approves Benlysta (belimumab) Autoinjector for children with systemic lupus erythematosus. News Release. GSK. May 20, 2024. Accessed May 24, 2024. https://us.gsk.com/en-us/media/press-releases/fda-approves-benlysta-belimumab-autoinjector-for-children-with-systemic-lupus-erythematosus/
2. FDA Advisory Committee Panel Strongly Recommends Approval of Shield™ Blood Test for Colorectal Cancer Screening as a Primary Non-Invasive Screening Option. News Release. Guardant. May 23, 2024. Accessed May 24, 2024. https://investors.guardanthealth.com/press-releases/press-releases/2024/FDA-Advisory-Committee-Panel-Strongly-Recommends-Approval-of-Shield-Blood-Test-for-Colorectal-Cancer-Screening-as-a-Primary-Non-Invasive-Screening-Option/default.aspx
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