Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review

Last year, more than 46 unique biosimilars have been approved by the EMA and / or US-FDA following patent expiry of the reference product. Biosimilars are not identical such as generics, but that version is very similar where show biosimilarity quality attributes (QAs) for the reference product is the basis of development and regulatory approval. Information about QAs rated for establishing biosimilarity not always available to the public, even though this information is essential to better understand the science behind the approval of biosimilars.

The purpose of this study to identify the type of QA is reported in the publication presents the biosimilarity assessment of biosimilars (intended) from time to time. publication of full-text English language serves biosimilarity assessment of QAs for biosimilars (intended) between 2000 and 2019 were identified from PubMed and EMBASE. Publications and QAs characteristics are classified into: structural (physicochemical properties, the primary structure, the high level structure (Hoss), post-translational modification (PTM), and the purity and impurities) and functional (biological activity and immunochemical) extracted from publications. Seventy-nine publications were identified (79% of open access, industry-sponsored 75%, 62%, including biosimilars are not approved, and 66% involving antibodies). biological activity (94%), physicochemical properties (81%), PTM (79%), the primary structure (77%) purity and feces (73%), Hoss (58%), and the activity of immunochemical: frequency varies on the type of QA Reporting (41%).

The number of publications increased from 6 (7%) during 2009 to 2011 to 62 (79%) during 2015-2019. Eighteen (28%) to report all types of QA publications relevant to the biologically-active substances. Reporting of most types of QA increased from time to time most evidenced by immunochemical activity (from 0% to 47%) that occurred after the EMA monoclonal antibodies (mAbs) guidline in 2012 and more publications on mAbs later when compared with the previous period. Biosimilarity assessment of QAs have been published in peer-reviewed publications to approximately 60% of biosimilars approved.

Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review
Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review

Publishing biosimilarity assessment and reporting QAs from time to time seem to be affected by regulatory actions that occurred in 2012-2015, including regulatory approval and the development of regulatory guidelines for biosimilars. The availability of complete biosimilarity assessment, accessible to the public and contains from QAs, as part of a reliable and transparent regulatory process, will contribute to improving the confidence and acceptance of biosimilars in clinical practice.

The dynamics of scientific publications serving biosimilarity assessment of QAs in relation to the regulatory approval of biosimilars by the EMA and / or US-FDA Footnote EMA: European Medicines Agency; US-FDA: United States Food and Drug Administration; EMA guidelines Monoclonal antibodies (mAbs) revision 0: Guideline on similar biological medicinal products containing monoclonal antibodies – the problem of non-clinical and clinical revision 0; Quality EMA guidelines (revision 0): guidelines on similar biological medicinal products cntaining biotechnology-derived proteins as active substance: quality issues (revision 1); US-FDA Quality Guideline revision 0: The quality considerations in demonstrating biosimilarity of therapeutic protein products to the reference product; guidelines for industry (revision 0).

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