{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["10"],"submitter":["Nupur N"],"pubmed_abstract":["Biopharmaceuticals are one of the fastest-growing sectors in the biotechnology industry. Within the umbrella of biopharmaceuticals, the biosimilar segment is expanding with currently over 200 approved biosimilars, globally. The key step towards achieving a successful biosimilar approval is to establish analytical and clinical biosimilarity with the innovator. The objective of an analytical biosimilarity study is to demonstrate a highly similar profile with respect to variations in critical quality attributes (CQAs) of the biosimilar product, and these variations must lie within the range set by the innovator. This comprises a detailed comparative structural and functional characterization using appropriate, validated analytical methods to fingerprint the molecule and helps reduce the econo"],"journal":["Frontiers in bioengineering and biotechnology"],"pagination":["832059"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8865741"],"repository":["biostudies-literature"],"pubmed_title":["Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms."],"pmcid":["PMC8865741"],"pubmed_authors":["Rathore AS","Gulliarme D","Nupur N","Joshi S"],"additional_accession":[]},"is_claimable":false,"name":"Analytical Similarity Assessment of Biosimilars: Global Regulatory Landscape, Recent Studies and Major Advancements in Orthogonal Platforms.","description":"Biopharmaceuticals are one of the fastest-growing sectors in the biotechnology industry. Within the umbrella of biopharmaceuticals, the biosimilar segment is expanding with currently over 200 approved biosimilars, globally. The key step towards achieving a successful biosimilar approval is to establish analytical and clinical biosimilarity with the innovator. The objective of an analytical biosimilarity study is to demonstrate a highly similar profile with respect to variations in critical quality attributes (CQAs) of the biosimilar product, and these variations must lie within the range set by the innovator. This comprises a detailed comparative structural and functional characterization using appropriate, validated analytical methods to fingerprint the molecule and helps reduce the econo","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022","modification":"2026-06-01T02:31:40.707Z","creation":"2024-10-16T14:54:24.49Z"},"accession":"S-EPMC8865741","cross_references":{"pubmed":["35223794"],"doi":["10.3389/fbioe.2022.832059"]}}