Abstract
A biosimilar is a biologic that is highly similar to a licensed biologic (the reference product) in terms of purity, safety and efficacy. If the reference product is licensed to treat multiple therapeutic indications, extrapolation of indications, i.e., approval of a biosimilar for use in an indication held by the reference product but not directly studied in a comparative clinical trial with the biosimilar, may be possible but has to be scientifically justified. Here, we describe the data required to establish biosimilarity and emphasize that indication extrapolation is based on scientific principles and known mechanism of action.
| Original language | English |
|---|---|
| Journal | Critical Reviews in Oncology/Hematology |
| DOIs | |
| Publication status | Accepted/In press - Jan 22 2016 |
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Keywords
- Biosimilar
- Cancer
- Extrapolation
- Monoclonal antibody
ASJC Scopus subject areas
- Oncology
- Hematology
- Geriatrics and Gerontology
Cite this
Biosimilars : Extrapolation for oncology. / Curigliano, Giuseppe; O'Connor, Darran P.; Rosenberg, Julie A.; Jacobs, Ira.
In: Critical Reviews in Oncology/Hematology, 22.01.2016.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Biosimilars
T2 - Extrapolation for oncology
AU - Curigliano, Giuseppe
AU - O'Connor, Darran P.
AU - Rosenberg, Julie A.
AU - Jacobs, Ira
PY - 2016/1/22
Y1 - 2016/1/22
N2 - A biosimilar is a biologic that is highly similar to a licensed biologic (the reference product) in terms of purity, safety and efficacy. If the reference product is licensed to treat multiple therapeutic indications, extrapolation of indications, i.e., approval of a biosimilar for use in an indication held by the reference product but not directly studied in a comparative clinical trial with the biosimilar, may be possible but has to be scientifically justified. Here, we describe the data required to establish biosimilarity and emphasize that indication extrapolation is based on scientific principles and known mechanism of action.
AB - A biosimilar is a biologic that is highly similar to a licensed biologic (the reference product) in terms of purity, safety and efficacy. If the reference product is licensed to treat multiple therapeutic indications, extrapolation of indications, i.e., approval of a biosimilar for use in an indication held by the reference product but not directly studied in a comparative clinical trial with the biosimilar, may be possible but has to be scientifically justified. Here, we describe the data required to establish biosimilarity and emphasize that indication extrapolation is based on scientific principles and known mechanism of action.
KW - Biosimilar
KW - Cancer
KW - Extrapolation
KW - Monoclonal antibody
UR - http://www.scopus.com/inward/record.url?scp=84977500678&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84977500678&partnerID=8YFLogxK
U2 - 10.1016/j.critrevonc.2016.06.002
DO - 10.1016/j.critrevonc.2016.06.002
M3 - Article
JO - Critical Reviews in Oncology/Hematology
JF - Critical Reviews in Oncology/Hematology
SN - 1040-8428
ER -