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Amgen faces first Neulasta biosimilar rival as FDA approves Mylan drug
https://pharmaphorum.com/news/amgen-neulasta-biosimilar-fda-mylan-fulphila/
Mylan
Mylan to develop Botox biosimilar with Revance
Mylan takes aim at Allergan’s off-patent blockbuster
FDA approves Mylan/Biocon Herceptin biosimilar
FDA finally gives cheaper copycat the thumbs-up
Samsung Bioepis Herceptin biosimilar approved in EU
Mylan and Biocon resolve biosimilar manufacturing issues
Hikma in dispute with FDA over Advair generic
Hikma to give up date in Q1 next year.
FDA rejects Mylan and Biocon biosimilar, citing manufacturing issues
Neulasta biosimilar hits trouble with regulators because of manufacturing issues
Copaxone first on FDA’s list for faster complex generic approvals
Teva will attempt to block generic launch in courts
Mylan finalises $465m deal with US government over EpiPen
Mylan finalises rebate deal with US government.
Biocon’s biosimilars withdrawn in EU
Regulators concerned over manufacturing standards.
