Biosimilars in Oncology: Latest Trends and Regulatory Status

Joshi, D; Khursheed, R; Gupta, S; Wadhwa, D; Singh, TG; Sharma, S; Porwal, S; Gauniyal, S; Vishwas, S; Goyal, S; Gupta, G; Eri, RD; Williams, KA; Dua, K; Singh, SK

Biosimilars in Oncology: Latest Trends and Regulatory Status

Joshi, D Khursheed, R Gupta, S Wadhwa, D Singh, TG Sharma, S Porwal, S Gauniyal, S Vishwas, S Goyal, S Gupta, G Eri, RD Williams, KA Dua, K

Singh, SK

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Publisher:: MDPI AG
Publication Type:: Journal Article
Citation:: Pharmaceutics, 14, (12), pp. 2721-2721

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Field	Value	Language
dc.contributor.author	Joshi, D
dc.contributor.author	Khursheed, R
dc.contributor.author	Gupta, S
dc.contributor.author	Wadhwa, D
dc.contributor.author	Singh, TG
dc.contributor.author	Sharma, S
dc.contributor.author	Porwal, S
dc.contributor.author	Gauniyal, S
dc.contributor.author	Vishwas, S
dc.contributor.author	Goyal, S
dc.contributor.author	Gupta, G
dc.contributor.author	Eri, RD
dc.contributor.author	Williams, KA
dc.contributor.author	Dua, K https://orcid.org/0000-0002-7507-1159
dc.contributor.author	Singh, SK
dc.date.accessioned	2022-12-06T11:29:52Z
dc.date.available	2022-12-06T11:29:52Z
dc.identifier.citation	Pharmaceutics, 14, (12), pp. 2721-2721
dc.identifier.issn	1999-4923
dc.identifier.uri	http://hdl.handle.net/10453/164160
dc.description.abstract	<jats:p>Biologic-based medicines are used to treat a variety of diseases and account for around one-quarter of the worldwide pharmaceutical market. The use of biologic medications among cancer patients has resulted in substantial advancements in cancer treatment and supportive care. Biosimilar medications (or biosimilars) are very similar to the reference biologic drugs, although they are not identical. As patent protection for some of the most extensively used biologics begins to expire, biosimilars have the potential to enhance access and provide lower-cost options for cancer treatment. Initially, regulatory guidelines were set up in Europe in 2003, and the first biosimilar was approved in 2006 in Europe. Many countries, including the United States of America (USA), Canada, and Japan, have adopted Europe’s worldwide regulatory framework. The use of numerous biosimilars in the treatment and supportive care of cancer has been approved and, indeed, the count is set to climb in the future around the world. However, there are many challenges associated with biosimilars, such as cost, immunogenicity, lack of awareness, extrapolation of indications, and interchangeability. The purpose of this review is to provide an insight into biosimilars, which include various options available for oncology, and the associated adverse events. We compare the regulatory guidelines for biosimilars across the world, and also present the latest trends and challenges in medical oncology both now and in the future, which will assist healthcare professionals, payers, and patients in making informed decisions, increasing the acceptance of biosimilars in clinical practice, increasing accessibility, and speeding up the health and economic benefits associated with biosimilars.</jats:p>
dc.language	en
dc.publisher	MDPI AG
dc.relation.ispartof	Pharmaceutics
dc.relation.isbasedon	10.3390/pharmaceutics14122721
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	1115 Pharmacology and Pharmaceutical Sciences
dc.title	Biosimilars in Oncology: Latest Trends and Regulatory Status
dc.type	Journal Article
utslib.citation.volume	14
utslib.for	1115 Pharmacology and Pharmaceutical Sciences
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Graduate School of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/Graduate School of Health/GSH.Pharmacy
utslib.copyright.status	open_access	*
dc.date.updated	2022-12-06T11:29:49Z
pubs.issue	12
pubs.publication-status	Published online
pubs.volume	14
utslib.citation.issue	12

Abstract:

Biologic-based medicines are used to treat a variety of diseases and account for around one-quarter of the worldwide pharmaceutical market. The use of biologic medications among cancer patients has resulted in substantial advancements in cancer treatment and supportive care. Biosimilar medications (or biosimilars) are very similar to the reference biologic drugs, although they are not identical. As patent protection for some of the most extensively used biologics begins to expire, biosimilars have the potential to enhance access and provide lower-cost options for cancer treatment. Initially, regulatory guidelines were set up in Europe in 2003, and the first biosimilar was approved in 2006 in Europe. Many countries, including the United States of America (USA), Canada, and Japan, have adopted Europe’s worldwide regulatory framework. The use of numerous biosimilars in the treatment and supportive care of cancer has been approved and, indeed, the count is set to climb in the future around the world. However, there are many challenges associated with biosimilars, such as cost, immunogenicity, lack of awareness, extrapolation of indications, and interchangeability. The purpose of this review is to provide an insight into biosimilars, which include various options available for oncology, and the associated adverse events. We compare the regulatory guidelines for biosimilars across the world, and also present the latest trends and challenges in medical oncology both now and in the future, which will assist healthcare professionals, payers, and patients in making informed decisions, increasing the acceptance of biosimilars in clinical practice, increasing accessibility, and speeding up the health and economic benefits associated with biosimilars.

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http://hdl.handle.net/10453/164160