Abstract
Biological oncology products are integral to cancer treatment, but their high costs pose challenges to patients, families, providers, and insurers. The introduction of biosimilar agents-molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biological drugs-provide opportunities both to improve health-care access and outcomes, and to reduce costs. Several international regulatory pathways have been developed to expedite entry of biosimilars into global marketplaces. The first wave of oncology biosimilar use was in Europe and India in 2007. Oncology biosimilars are now widely marketed in several countries in Europe, and in Australia, Japan, China, Russia, India, and South Korea. Their use is emerging worldwide, with the notable exception of the USA, where several regulatory and cost barriers to biosimilar approval exist. In this Review, we discuss oncology biosimilars and summarise their regulatory frameworks, clinical experiences, and safety concerns.
| Original language | English (US) |
|---|---|
| Pages (from-to) | e594-e605 |
| Journal | The Lancet Oncology |
| Volume | 15 |
| Issue number | 13 |
| DOIs | |
| State | Published - Jan 1 2014 |
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ASJC Scopus subject areas
- Oncology
Cite this
Regulatory and clinical considerations for biosimilar oncology drugs. / Bennett, C. L.; Chen, B.; Wyatt, M. D.; Schulz, R. M.; Georgantopoulos, P.; Kessler, S.; Qureshi, Z. P.; Lu, Z. K.; Love, B. L.; Noxon, V.; Bian, J.; Ray, P.; Ablin, R. J.; Hruskesky, W. J.; Hermanson, T.; Raisch, D. W.; Bobolts, L.; Armitage, M.; Hrushesky, W. J.; Macdougall, I. C.; Sartor, O.; Armitage, James Olen.
In: The Lancet Oncology, Vol. 15, No. 13, 01.01.2014, p. e594-e605.Research output: Contribution to journal › Review article
}
TY - JOUR
T1 - Regulatory and clinical considerations for biosimilar oncology drugs
AU - Bennett, C. L.
AU - Chen, B.
AU - Wyatt, M. D.
AU - Schulz, R. M.
AU - Georgantopoulos, P.
AU - Kessler, S.
AU - Qureshi, Z. P.
AU - Lu, Z. K.
AU - Love, B. L.
AU - Noxon, V.
AU - Bian, J.
AU - Ray, P.
AU - Ablin, R. J.
AU - Hruskesky, W. J.
AU - Hermanson, T.
AU - Raisch, D. W.
AU - Bobolts, L.
AU - Armitage, M.
AU - Hrushesky, W. J.
AU - Macdougall, I. C.
AU - Sartor, O.
AU - Armitage, James Olen
PY - 2014/1/1
Y1 - 2014/1/1
N2 - Biological oncology products are integral to cancer treatment, but their high costs pose challenges to patients, families, providers, and insurers. The introduction of biosimilar agents-molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biological drugs-provide opportunities both to improve health-care access and outcomes, and to reduce costs. Several international regulatory pathways have been developed to expedite entry of biosimilars into global marketplaces. The first wave of oncology biosimilar use was in Europe and India in 2007. Oncology biosimilars are now widely marketed in several countries in Europe, and in Australia, Japan, China, Russia, India, and South Korea. Their use is emerging worldwide, with the notable exception of the USA, where several regulatory and cost barriers to biosimilar approval exist. In this Review, we discuss oncology biosimilars and summarise their regulatory frameworks, clinical experiences, and safety concerns.
AB - Biological oncology products are integral to cancer treatment, but their high costs pose challenges to patients, families, providers, and insurers. The introduction of biosimilar agents-molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biological drugs-provide opportunities both to improve health-care access and outcomes, and to reduce costs. Several international regulatory pathways have been developed to expedite entry of biosimilars into global marketplaces. The first wave of oncology biosimilar use was in Europe and India in 2007. Oncology biosimilars are now widely marketed in several countries in Europe, and in Australia, Japan, China, Russia, India, and South Korea. Their use is emerging worldwide, with the notable exception of the USA, where several regulatory and cost barriers to biosimilar approval exist. In this Review, we discuss oncology biosimilars and summarise their regulatory frameworks, clinical experiences, and safety concerns.
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UR - http://www.scopus.com/inward/citedby.url?scp=84924854592&partnerID=8YFLogxK
U2 - 10.1016/S1470-2045(14)70365-1
DO - 10.1016/S1470-2045(14)70365-1
M3 - Review article
VL - 15
SP - e594-e605
JO - The Lancet Oncology
JF - The Lancet Oncology
SN - 1470-2045
IS - 13
ER -