FDA Approves First Eylea Biosimilars
On May 20, 2024, the U.S. Food and Drug Administration (FDA) approved Opuviz™ (aflibercept-yszy – Samsung Bioepis/Biogen) injection and Yesafili™ (aflibercept- jbvf – Biocon Biologics) injection, the first biosimilars for Eylea® (aflibercept – Regeneron) injection, 2mg. Each is indicated to treat the same main conditions as Eylea – neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), diabetic retinopathy (DR), and macular edema after retinal vein occlusion (RVO). Eylea also is approved to treat retinopathy of prematurity (ROP). Aflibercept 2mg is injected intravitreally by an ophthalmic specialist in a sterile setting – usually once every month or once every two months. Both Opuviz and Yesafili are interchangeable with Eylea. In states where pharmacy regulations allow substitution, either can be dispensed instead of Eylea without contacting the prescriber for permission. In the U.S., Opuviz will be distributed by Biogen. No information is available for pricing of either biosimilar, and their possible launch dates are undetermined due to continuing patent lawsuits. In August 2023, Regeneron introduced an 8mg strength, Eylea® HD injection, which can be given once every two months or every four months. This new formulation is patent-protected until at least 2039. For 2023, U.S. sales of Eylea amounted to approximately $5.9 billion, including about $166 million from the 8mg strength, according to Regeneron. Here is the full prescribing information for Opuviz and here for Yesafili.
Subcutaneous Benlysta Approved for Pediatric Lupus
The subcutaneously (SC) autoinjected form of Benlysta® (belimumab), was FDA approved on May 16, 2024, to treat active cases of systemic lupus erythematosus (SLE) for children who are five years old and older. The intravenous (IV) formulation of GSK’s B-lymphocyte stimulator (BLyS)-specific inhibiting monoclonal antibody has been approved to treat SLE for children in the same age group since July 2022, but the infusions have to be administered by a healthcare professional – usually in a healthcare facility. Caregivers may be able to give SC Benlysta injections at home. Recommended SC dosing is 200mg given once every two weeks for children who weigh between 15kg (33 pounds) and 40kg (88 pounds) and once every week for those who weigh 40kg or more. Infusions, which are given once every four weeks, are dosed at 10mg/kg. SLE is an autoimmune disease characterized by inflammation in connective tissues. It can affect the joints and numerous organs, including the heart, kidneys, and skin. Benlysta blocks the activity of a protein, BLyS, that is elevated in patients who have SLE, contributing to the production of cells that attack patients’ blood vessels and organ systems. The Lupus Foundation of America believes that around 6,000 U.S. children and teens have lupus, which tends to cause more kidney and other organ damage for pediatric patients than for adults. Benlysta’s revised prescribing information is here.
Updated DrugWatch Document Available
The Emerging Therapeutics department has updated DrugWatch, a document that highlights near-term pipeline drugs as well as potential new generic opportunities. The DrugWatch document is attached
Updates for the MASLD/MASH Drugs Issues Document
The Emerging Therapeutics department has revised the “Metabolic Dysfunction-Associated Steatotic Liver Disease/Metabolic Dysfunction-Associated Steatohepatitis” Issues Document to introduce new terminology, include information on a recently approved product, and summarize pipeline drugs that may be close to FDA approval.