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Samsung Bioepis' Enbrel biosimilar candidate SB4 accepted for review by EMA

Samsung Bioepis' Enbrel biosimilar candidate SB4 accepted for review by EMA

21-01-2015

South Korea’s Samsung Bioepis says that the Marketing Authorization Application for its Enbrel (etanercept)…

AmgenAnti-Arthritics/RheumaticsBiogen IdecBiosimilarsBiotechnologyEnbrelEuropePfizerRegulationSamsung Bioepis

Hospira submits new BLA for epoetin alfa biosimilar In USA

12-01-2015

US injectable drugs and infusion technologies and biosimilars developer Hospira has submitted a Biologics…

AmgenBiosimilarsBiotechnologyepoetinEpogenHematologyHospiraJanssenJohnson & JohnsonProcritRegulationRetacritUSA

Sandoz’ Neupogen biosimilar backed by FDA advisory panel

Sandoz’ Neupogen biosimilar backed by FDA advisory panel

08-01-2015

The US Food and Drug Administration Oncologic Drugs Advisory Committee (ODAC), in a unanimous vote, recommended…

AmgenBiosimilarsBiotechnologyFilgrastimNeupogenNovartisOncologyRegulationSandozUSAZarxio

FDA staffers back approval of Novartis' biosimilar of Amgen's Neupogen

FDA staffers back approval of Novartis' biosimilar of Amgen's Neupogen

06-01-2015

In briefing papers ahead of an advisory committee meeting, agency staff at the US Food and Drug Administration…

AmgenBiosimilarsBiotechnologyImmunologicalsNeupogenNovartisRegulationUSA

Sandoz demonstrates safety and efficacy of Neupogen biosimilar

Sandoz demonstrates safety and efficacy of Neupogen biosimilar

08-12-2014

Sandoz, the generics subsidiary of Swiss pharma major Novartis, has today released Phase III data that…

AmgenBiosimilarsBiotechnologyFilgrastimNeupogenNovartisOncologyResearchSandoz

Ph III study of Amgen’s Humira biosimilar ABP 501 meets endpoint in psoriasis

Ph III study of Amgen’s Humira biosimilar ABP 501 meets endpoint in psoriasis

09-10-2014

US biotech major Amgen says its Phase III study evaluating the efficacy and safety of its biosimilar…

AbbVieABP 501AmgenAnti-Arthritics/RheumaticsBiosimilarsBiotechnologyDermatologicalsHumiraResearchUSA

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