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Growth factors / Hematology / Pharmacology / Filgrastim / Cytokines / Biosimilar / Granulocyte colony-stimulating factor / Biologic / Hematopoietic stem cell transplantation / Biology / Medicine / Amgen


ODAC Brief BLA[removed]EP2006, a proposed biosimilar to Neupogen FDA Briefing Document
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Company

Novartis / Amgen / GM / Sandoz Inc. / /

Country

United States / /

Event

FDA Phase / /

IndustryTerm

biological products / proposed commercial product / drug product / comparator product / reference product / biosimilar product / biological product / manufacturing / biosimilar biological product / clinical product / biosimilar biological products / proposed biosimilar product / /

MedicalCondition

congenital neutropenia / breast cancer receiving TAC chemotherapy / neutropenia / chronic administration / fever / febrile neutropenia / neutropenia indications / infections / Acute Myelogenous Leukemia / severe neutropenia / idiopathic neutropenia / cyclic neutropenia / /

MedicalTreatment

leukapheresis / Chemotherapy / /

Movie

A.D. / /

Organization

Food and Drug Administration / UV CD / Review Division / European Union / Neupogen FDA Briefing Document Oncologic Drugs Advisory Committee / Advisory Committee / /

Person

Obama / /

Position

President / EXECUTIVE / CMC Executive / /

Product

Neupogen / EP2006 / /

Technology

Chemotherapy / transplantation / pharmacodynamics / stem cells / /

SocialTag