Approval of Accord’s Trastuzumab Biosimilar: On September 18, 2024, Accord announced that the Food and Drug Administration (FDA) approved a 420 mg dosage of HERCESSI (trastuzumab-strf), a biosimilar to Genentech’s HERCEPTIN (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma. As we previously reported, HERCESSI was approved earlier this year by the FDA at a dosage of 150 mg. According to Binish Chudgar, vice chairman and managing director of Intas Pharmaceuticals (of which Accord is a specialty subdivision), “[t]he FDA’s approval of both strengths of HERCESSI marks the beginning of Accord BioPharma’s journey to bring a portfolio of biosimilars to the U.S. that can help achieve significant savings.”
Approval of Amgen’s Aflibercept Biosimilar: On August 23, 2024, the FDA approved Amgen’s aflibercept biosimilar PAVBLU (aflibercept-ayyh), a biosimilar of Regeneron’s EYLEA®. According to the approval letter, “Pavblu is indicated for neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).” PAVBLU is the fifth aflibercept biosimilar to be approved by the FDA, following approval of Mylan/Biocon’s YESAFILI (aflibercept-jbvf) in May 2024, Samsung Bioepis’s OPUVIZ (aflibercept-yszy) in May 2024, Formycon’s AHZANTIVE (aflibercept-mrbb) in July 2024, and Sandoz’s ENZEEVU (aflibercept-abzv) in August 2024.
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