Articles with "reference biologic" as a keyword



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Therapeutic Equivalence of Biosimilar and Reference Biologic Drugs in Rheumatoid Arthritis

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Published in 2023 at "JAMA Network Open"

DOI: 10.1001/jamanetworkopen.2023.15872

Abstract: Key Points Question Are biosimilars of adalimumab, etanercept, and infliximab associated with equivalent treatment compared with their reference biologic drugs for the management of rheumatoid arthritis? Findings In this systematic review and meta-analysis of 25… read more here.

Keywords: reference biologic; biologic drugs; rheumatoid arthritis;
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Methodologic considerations for noninterventional studies of switching from reference biologic to biosimilars

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Published in 2019 at "Pharmacoepidemiology and Drug Safety"

DOI: 10.1002/pds.4809

Abstract: As more biosimilars become available in the United States, postapproval noninterventional studies describing biosimilar switching and comparing effectiveness and/or safety between switchers and nonswitchers will play a key role in generating real‐world evidence to inform… read more here.

Keywords: studies switching; reference biologic; noninterventional studies; switching reference ... See more keywords
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A review of the totality of evidence supporting the development and approval of a pegfilgrastim biosimilar (LA-EP2006)

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Published in 2022 at "Current Medical Research and Opinion"

DOI: 10.1080/03007995.2022.2061707

Abstract: Abstract Objective The totality-of-evidence approach requires that similarity between a proposed biosimilar and a reference biologic is demonstrated across a range of analytical, preclinical, and clinical parameters to establish biosimilarity. We describe the totality of… read more here.

Keywords: reference biologic; reference; pegfilgrastim; totality evidence ... See more keywords
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A retrospective review of the real-world experience of the Pegfilgrastim biosimilar (Lapelga®) to the reference biologic (Neulasta®)

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Published in 2020 at "Journal of Oncology Pharmacy Practice"

DOI: 10.1177/1078155220974085

Abstract: Introduction Cancer patients receiving myelosuppressive chemotherapy are vulnerable to febrile neutropenia (FN) which contributes to poor treatment outcomes. The use of granulocyte colony-stimulating factors is administered to prevent chemotherapy-induced neutropenia. The introduction of biosimilars has… read more here.

Keywords: reference biologic; review; reference; pegfilgrastim ... See more keywords
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The Real-World Experience of the Biosimilar (Grastofil®) to the Reference Biologic (Neupogen®) in Breast Cancer and Lymphoma: A Canadian Single-Centre Retrospective Study

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Published in 2022 at "Current Oncology"

DOI: 10.3390/curroncol29030115

Abstract: Febrile neutropenia (FN) is a common side effect of cytotoxic chemotherapy that may result in poor treatment outcomes. The short acting granulocyte colony stimulating factors (G-CSF) act to stimulate granulocytes to increase production of white… read more here.

Keywords: reference biologic; grastofil; breast cancer; neupogen ... See more keywords