While data on functional endpoints are still to come, Avidity Biosciences Inc. executives said the firm is moving ahead with plans for a BLA filing by the end of 2025 for del-zota, an antibody-oligonucleotide conjugate, in Duchenne muscular dystrophy with mutations amenable to exon 44 skipping (DMD44), based on positive top-line data that analysts say bode well for Avidity’s other late-stage programs targeting rare neuromuscular diseases.
Celltrion Inc. is on a biosimilar roll with the U.S. FDA this month, having gained clearance of Stoboclo and Osenvelt as products referencing Amgen Inc.’s biologic, denosumab (Prolia, Xgeva), along with Omlyclo becoming the first and only interchangeable biosimilar to omalizumab (Xolair, Genentech Inc. and Novartis AG).
The U.S. FDA has greenlit the first steps of Uniqure NV’s accelerated approval pathway for gene therapy AMT-130 to treat Huntington’s disease. The agency said data from the ongoing phase I/II studies compared to natural history external control are muscular enough to get the process going without having to dive into additional studies.
Samsung Bioepis Co. Ltd., of Incheon, South Korea, gained U.S. FDA approval of Epysqli (eculizumab-aagh) as the second biosimilar product to Alexion Pharmaceuticals Inc.’s Soliris (eculizumab) to treat two rare diseases. The regulatory clearance July 22 grants use of Epysqli to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome – two rare hematologic- and kidney-related disorders known to affect about 50,000 and 5,000 patients in the U.S., respectively.
The U.S. FDA approved three biosimilar products from Samsung Bioepis Co. Ltd., Tanvex Biopharma Inc. and Formycon AG as follow-on biologics to Stelara (ustekinumab), Neupogen (filgrastim) and Eylea (aflibercept), respectively, on June 28.
Although the U.S. FDA unexpectedly sprang the news on Eli Lilly and Co. that it would hold an advisory committee meeting on the BLA for the company’s Alzheimer’s disease drug, donanemab, the agency’s briefing document for the June 10 meeting doesn’t appear to hold any surprises.
South Korea’s Celltrion Inc. secured May 22 the European Commission’s go-ahead for Omlyclo (CT-P39) to be the first biosimilar to Genentech Inc./Novartis AG’s Xolair (omalizumab) in Europe for three of its major indications.
South Korea’s Celltrion Inc. secured May 22 the European Commission’s go-ahead for Omlyclo (CT-P39) to be the first biosimilar to Genentech Inc./Novartis AG’s Xolair (omalizumab) in Europe for three of its major indications.
The U.S. FDA approved the country’s first two interchangeable biosimilars, or copy products, of Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 20, to treat four eye-related conditions. The FDA granted the approvals to U.S.- and India-based Johnson & Johnson Services Inc./Biocon Biologics Ltd.’s Yesafili (aflibercept-jbvf; M-710) and South Korea’s Samsung Bioepis Co. Ltd.’s Opuviz (aflibercept-yszy; SB-15).
Biosimilar competition to Amgen Inc.’s denosumab (Prolia/Xgeva) is rising globally, with Mabwell (Shanghai) Bioscience Co. Ltd. gaining the latest China NMPA approval of Maiweijian (TK-006) on April 8. Mabwell’s wholly owned subsidiary, Jiangsu T-mab Biopharma Co. Ltd., gained NMPA clearance of Maiweijian (120 mg) as the first denosumab biosimilar for the indications of U.S.-licensed Xgeva for bone-related diseases.
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