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Safety of Biologics, Including Biosimilars: Perspectives on Current Status and Future Direction

Drug safety, 2018-11, Vol.41 (11), p.1013-1022 [Peer Reviewed Journal]

Springer International Publishing AG, part of Springer Nature 2018 ;Copyright Springer Nature B.V. Nov 2018 ;ISSN: 0114-5916 ;EISSN: 1179-1942 ;DOI: 10.1007/s40264-018-0684-9 ;PMID: 29796832

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Title:
Safety of Biologics, Including Biosimilars: Perspectives on Current Status and Future Direction
Author: Ingrasciotta, Ylenia ; Cutroneo, Paola M. ; Marcianò, Ilaria ; Giezen, Thijs ; Atzeni, Fabiola ; Trifirò, Gianluca
Subjects: Autoimmune diseases ; Biological products ; Biological Products - adverse effects ; Biological Products - immunology ; Biological Products - therapeutic use ; Biosimilar Pharmaceuticals - adverse effects ; Biosimilar Pharmaceuticals - therapeutic use ; Brand names ; Clinical medicine ; Cost control ; Drug and Narcotic Control - organization & administration ; Drug Safety and Pharmacovigilance ; Expenditures ; Humans ; Immunogenicity ; Inflammatory bowel disease ; Innovations ; Leading Article ; Manufacturing ; Marketing ; Medicine ; Medicine & Public Health ; Patient Safety ; Pharmaceuticals ; Pharmacology ; Pharmacology/Toxicology ; Pharmacovigilance ; Policy ; Prescription drugs ; Product safety ; Product Surveillance, Postmarketing - standards ; Regulatory agencies ; Renal failure ; Rheumatoid arthritis ; Rheumatology ; Risk Assessment ; Safety ; Substitution reactions ; Therapeutic Equivalency ; Toxicity
Is Part Of: Drug safety, 2018-11, Vol.41 (11), p.1013-1022
Description: In recent years, marketing of highly innovative and costly biologics improved the management of high-burden diseases such as autoimmune diseases, cancers, and chronic renal failure. Several widely prescribed biologics have recently lost or will shortly lose their patents, thus opening avenues to the marketing of a growing number of biosimilars worldwide, which are products similar in terms of quality, safety, and efficacy to already licensed reference products, thus allowing for potential savings in pharmaceutical expenditure. Numerous debates about the interchangeability between biosimilars and reference products are still ongoing, owing to concerns about potential immunogenicity raised by switching, which may cause a lack of effect and toxicity. Patients successfully treated with biologic therapy may theoretically receive biosimilars to contain costs, if reference product and related biosimilar are judged as interchangeable. However, the positions of regulatory agencies on the interchangeability and automatic substitution of biologics with biosimilars are very different. The benefit-risk profile of biosimilars has been often questioned by clinicians owing to the limited amount of pre-marketing information on clinical efficacy and safety, despite biosimilarity being based on a comparability exercise with the reference product to gain the biosimilar approval. Nevertheless, after more than 10 years of marketing from the first biosimilar approval in Europe, no proof of differences in terms of the safety profile of biosimilars and originators has been reported. In this context, post-marketing evaluation of both biologics and biosimilars safety profiles through analyses from spontaneous reporting databases and claims databases is crucial. An important issue for the pharmacovigilance of biologics concerns the traceability, indicating the brand name and batch number in spontaneous adverse drug reaction reports, but this requirement is not frequently addressed. This review aims to provide an overview of the characteristics and potential challenges in the safety profile assessment of biologics with a focus on the post-marketing setting.
Publisher: Cham: Springer International Publishing
Language: English
Identifier: ISSN: 0114-5916
EISSN: 1179-1942
DOI: 10.1007/s40264-018-0684-9
PMID: 29796832
Source: MEDLINE
ProQuest Central

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Safety of Biologics, Including Biosimilars: Perspectives on Current Status and Future Direction

Springer International Publishing AG, part of Springer Nature 2018 ;Copyright Springer Nature B.V. Nov 2018 ;ISSN: 0114-5916 ;EISSN: 1179-1942 ;DOI: 10.1007/s40264-018-0684-9 ;PMID: 29796832

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