Assessing Analytical Similarity of Proposed Amgen Biosimilar ABP 501 to Adalimumab
Background ABP 501 is being developed as a biosimilar to adalimumab. Comprehensive comparative analytical characterization studies have been conducted and completed. Objective The objective of this study was to assess analytical similarity between ABP 501 and two adalimumab reference products (RPs),...
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| Veröffentlicht in: | BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy biopharmaceuticals, and gene therapy, 2016-08, Vol.30 (4), p.321-338 |
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| creator | Liu, Jennifer Eris, Tamer Li, Cynthia Cao, Shawn Kuhns, Scott |
| description | Background
ABP 501 is being developed as a biosimilar to adalimumab. Comprehensive comparative analytical characterization studies have been conducted and completed.
Objective
The objective of this study was to assess analytical similarity between ABP 501 and two adalimumab reference products (RPs), licensed by the United States Food and Drug Administration (adalimumab [US]) and authorized by the European Union (adalimumab [EU]), using state-of-the-art analytical methods.
Methods
Comprehensive analytical characterization incorporating orthogonal analytical techniques was used to compare products. Physicochemical property comparisons comprised the primary structure related to amino acid sequence and post-translational modifications including glycans; higher-order structure; primary biological properties mediated by target and receptor binding; product-related substances and impurities; host-cell impurities; general properties of the finished drug product, including strength and formulation; subvisible and submicron particles and aggregates; and forced thermal degradation.
Results
ABP 501 had the same amino acid sequence and similar post-translational modification profiles compared with adalimumab RPs. Primary structure, higher-order structure, and biological activities were similar for the three products. Product-related size and charge variants and aggregate and particle levels were also similar. ABP 501 had very low residual host-cell protein and DNA. The finished ABP 501 drug product has the same strength with regard to protein concentration and fill volume as adalimumab RPs. ABP 501 and the RPs had a similar stability profile both in normal storage and thermal stress conditions.
Conclusion
Based on the comprehensive analytical similarity assessment, ABP 501 was found to be similar to adalimumab with respect to physicochemical and biological properties. |
| doi_str_mv | 10.1007/s40259-016-0184-3 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4972872</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1809601788</sourcerecordid><originalsourceid>FETCH-LOGICAL-c503t-100230b5a8c96fdd542a4c8ec167fce7715b45baa1907ae2d6733b5535395f523</originalsourceid><addsrcrecordid>eNqNkU1rFTEYhYMotlZ_gBsJuOlm9E0y-doI02K1ULBoC-5CJpO5psxMrsmMcP99c51aWkFwERI4z3uSk4PQawLvCIB8n2ugXFdARFmqrtgTdEiI1BXR8P3p7zOrlIL6AL3I-QYABNPyOTqgshaEgDxEX5ucfc5h2uBmssNuDs4O-FsYw2BTmHc49vgyxW3MvsPNuPETPgkxrzpuTi4xB4LniJvODmFcRtu-RM96O2T_6m4_QtdnH69OP1cXXz6dnzYXlePA5qokoAxabpXTou86XlNbO-UdEbJ3XkrC25q31pYw0nraCclYyznjTPOeU3aEPqy-26Udfef8NCc7mG0Ko007E20wj5Up_DCb-MvUWlIl9wbHdwYp_lx8ns0YsvPDYCcfl2yIIlwCE1z_BwpaAJFKFfTtX-hNXFL52z1FidCgKRSKrJRLMefk-_t3EzD7cs1arinlmn25hpWZNw8D30_8abMAdAVykaaNTw-u_qfrLZmTrcc</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1821690920</pqid></control><display><type>article</type><title>Assessing Analytical Similarity of Proposed Amgen Biosimilar ABP 501 to Adalimumab</title><source>MEDLINE</source><source>SpringerLink Journals</source><creator>Liu, Jennifer ; Eris, Tamer ; Li, Cynthia ; Cao, Shawn ; Kuhns, Scott</creator><creatorcontrib>Liu, Jennifer ; Eris, Tamer ; Li, Cynthia ; Cao, Shawn ; Kuhns, Scott</creatorcontrib><description>Background
ABP 501 is being developed as a biosimilar to adalimumab. Comprehensive comparative analytical characterization studies have been conducted and completed.
Objective
The objective of this study was to assess analytical similarity between ABP 501 and two adalimumab reference products (RPs), licensed by the United States Food and Drug Administration (adalimumab [US]) and authorized by the European Union (adalimumab [EU]), using state-of-the-art analytical methods.
Methods
Comprehensive analytical characterization incorporating orthogonal analytical techniques was used to compare products. Physicochemical property comparisons comprised the primary structure related to amino acid sequence and post-translational modifications including glycans; higher-order structure; primary biological properties mediated by target and receptor binding; product-related substances and impurities; host-cell impurities; general properties of the finished drug product, including strength and formulation; subvisible and submicron particles and aggregates; and forced thermal degradation.
Results
ABP 501 had the same amino acid sequence and similar post-translational modification profiles compared with adalimumab RPs. Primary structure, higher-order structure, and biological activities were similar for the three products. Product-related size and charge variants and aggregate and particle levels were also similar. ABP 501 had very low residual host-cell protein and DNA. The finished ABP 501 drug product has the same strength with regard to protein concentration and fill volume as adalimumab RPs. ABP 501 and the RPs had a similar stability profile both in normal storage and thermal stress conditions.
Conclusion
Based on the comprehensive analytical similarity assessment, ABP 501 was found to be similar to adalimumab with respect to physicochemical and biological properties.</description><identifier>ISSN: 1173-8804</identifier><identifier>EISSN: 1179-190X</identifier><identifier>DOI: 10.1007/s40259-016-0184-3</identifier><identifier>PMID: 27461107</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Adalimumab - chemistry ; Adalimumab - pharmacology ; Animals ; Antibodies ; Arthritis ; Biological products ; Biomedical and Life Sciences ; Biomedicine ; Biosimilar Pharmaceuticals - analysis ; Biosimilar Pharmaceuticals - chemistry ; Biosimilar Pharmaceuticals - pharmacology ; Calorimetry, Differential Scanning ; Cancer Research ; CHO Cells - drug effects ; Chromatography ; Chromatography, High Pressure Liquid - methods ; Circular Dichroism ; Cricetulus ; Drug Stability ; Dynamic Light Scattering ; Electrophoresis, Capillary - methods ; Information services ; Isoelectric Point ; Manufacturing ; Molecular Medicine ; Original ; Original Research Article ; Peptide Mapping ; Peptides ; Pharmaceutical industry ; Pharmacotherapy ; Product development ; Quality ; Spectroscopy, Fourier Transform Infrared ; Technical communication ; Tumor necrosis factor-TNF ; Ultracentrifugation</subject><ispartof>BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy, 2016-08, Vol.30 (4), p.321-338</ispartof><rights>The Author(s) 2016</rights><rights>Copyright Springer Science & Business Media Aug 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c503t-100230b5a8c96fdd542a4c8ec167fce7715b45baa1907ae2d6733b5535395f523</citedby><cites>FETCH-LOGICAL-c503t-100230b5a8c96fdd542a4c8ec167fce7715b45baa1907ae2d6733b5535395f523</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s40259-016-0184-3$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s40259-016-0184-3$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27461107$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Liu, Jennifer</creatorcontrib><creatorcontrib>Eris, Tamer</creatorcontrib><creatorcontrib>Li, Cynthia</creatorcontrib><creatorcontrib>Cao, Shawn</creatorcontrib><creatorcontrib>Kuhns, Scott</creatorcontrib><title>Assessing Analytical Similarity of Proposed Amgen Biosimilar ABP 501 to Adalimumab</title><title>BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy</title><addtitle>BioDrugs</addtitle><addtitle>BioDrugs</addtitle><description>Background
ABP 501 is being developed as a biosimilar to adalimumab. Comprehensive comparative analytical characterization studies have been conducted and completed.
Objective
The objective of this study was to assess analytical similarity between ABP 501 and two adalimumab reference products (RPs), licensed by the United States Food and Drug Administration (adalimumab [US]) and authorized by the European Union (adalimumab [EU]), using state-of-the-art analytical methods.
Methods
Comprehensive analytical characterization incorporating orthogonal analytical techniques was used to compare products. Physicochemical property comparisons comprised the primary structure related to amino acid sequence and post-translational modifications including glycans; higher-order structure; primary biological properties mediated by target and receptor binding; product-related substances and impurities; host-cell impurities; general properties of the finished drug product, including strength and formulation; subvisible and submicron particles and aggregates; and forced thermal degradation.
Results
ABP 501 had the same amino acid sequence and similar post-translational modification profiles compared with adalimumab RPs. Primary structure, higher-order structure, and biological activities were similar for the three products. Product-related size and charge variants and aggregate and particle levels were also similar. ABP 501 had very low residual host-cell protein and DNA. The finished ABP 501 drug product has the same strength with regard to protein concentration and fill volume as adalimumab RPs. ABP 501 and the RPs had a similar stability profile both in normal storage and thermal stress conditions.
Conclusion
Based on the comprehensive analytical similarity assessment, ABP 501 was found to be similar to adalimumab with respect to physicochemical and biological properties.</description><subject>Adalimumab - chemistry</subject><subject>Adalimumab - pharmacology</subject><subject>Animals</subject><subject>Antibodies</subject><subject>Arthritis</subject><subject>Biological products</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Biosimilar Pharmaceuticals - analysis</subject><subject>Biosimilar Pharmaceuticals - chemistry</subject><subject>Biosimilar Pharmaceuticals - pharmacology</subject><subject>Calorimetry, Differential Scanning</subject><subject>Cancer Research</subject><subject>CHO Cells - drug effects</subject><subject>Chromatography</subject><subject>Chromatography, High Pressure Liquid - methods</subject><subject>Circular Dichroism</subject><subject>Cricetulus</subject><subject>Drug Stability</subject><subject>Dynamic Light Scattering</subject><subject>Electrophoresis, Capillary - methods</subject><subject>Information services</subject><subject>Isoelectric Point</subject><subject>Manufacturing</subject><subject>Molecular Medicine</subject><subject>Original</subject><subject>Original Research Article</subject><subject>Peptide Mapping</subject><subject>Peptides</subject><subject>Pharmaceutical industry</subject><subject>Pharmacotherapy</subject><subject>Product development</subject><subject>Quality</subject><subject>Spectroscopy, Fourier Transform Infrared</subject><subject>Technical communication</subject><subject>Tumor necrosis factor-TNF</subject><subject>Ultracentrifugation</subject><issn>1173-8804</issn><issn>1179-190X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqNkU1rFTEYhYMotlZ_gBsJuOlm9E0y-doI02K1ULBoC-5CJpO5psxMrsmMcP99c51aWkFwERI4z3uSk4PQawLvCIB8n2ugXFdARFmqrtgTdEiI1BXR8P3p7zOrlIL6AL3I-QYABNPyOTqgshaEgDxEX5ucfc5h2uBmssNuDs4O-FsYw2BTmHc49vgyxW3MvsPNuPETPgkxrzpuTi4xB4LniJvODmFcRtu-RM96O2T_6m4_QtdnH69OP1cXXz6dnzYXlePA5qokoAxabpXTou86XlNbO-UdEbJ3XkrC25q31pYw0nraCclYyznjTPOeU3aEPqy-26Udfef8NCc7mG0Ko007E20wj5Up_DCb-MvUWlIl9wbHdwYp_lx8ns0YsvPDYCcfl2yIIlwCE1z_BwpaAJFKFfTtX-hNXFL52z1FidCgKRSKrJRLMefk-_t3EzD7cs1arinlmn25hpWZNw8D30_8abMAdAVykaaNTw-u_qfrLZmTrcc</recordid><startdate>20160801</startdate><enddate>20160801</enddate><creator>Liu, Jennifer</creator><creator>Eris, Tamer</creator><creator>Li, Cynthia</creator><creator>Cao, Shawn</creator><creator>Kuhns, Scott</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>4T-</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M7P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>7QO</scope><scope>8FD</scope><scope>FR3</scope><scope>P64</scope><scope>5PM</scope></search><sort><creationdate>20160801</creationdate><title>Assessing Analytical Similarity of Proposed Amgen Biosimilar ABP 501 to Adalimumab</title><author>Liu, Jennifer ; Eris, Tamer ; Li, Cynthia ; Cao, Shawn ; Kuhns, Scott</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c503t-100230b5a8c96fdd542a4c8ec167fce7715b45baa1907ae2d6733b5535395f523</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adalimumab - chemistry</topic><topic>Adalimumab - pharmacology</topic><topic>Animals</topic><topic>Antibodies</topic><topic>Arthritis</topic><topic>Biological products</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Biosimilar Pharmaceuticals - analysis</topic><topic>Biosimilar Pharmaceuticals - chemistry</topic><topic>Biosimilar Pharmaceuticals - pharmacology</topic><topic>Calorimetry, Differential Scanning</topic><topic>Cancer Research</topic><topic>CHO Cells - drug effects</topic><topic>Chromatography</topic><topic>Chromatography, High Pressure Liquid - methods</topic><topic>Circular Dichroism</topic><topic>Cricetulus</topic><topic>Drug Stability</topic><topic>Dynamic Light Scattering</topic><topic>Electrophoresis, Capillary - methods</topic><topic>Information services</topic><topic>Isoelectric Point</topic><topic>Manufacturing</topic><topic>Molecular Medicine</topic><topic>Original</topic><topic>Original Research Article</topic><topic>Peptide Mapping</topic><topic>Peptides</topic><topic>Pharmaceutical industry</topic><topic>Pharmacotherapy</topic><topic>Product development</topic><topic>Quality</topic><topic>Spectroscopy, Fourier Transform Infrared</topic><topic>Technical communication</topic><topic>Tumor necrosis factor-TNF</topic><topic>Ultracentrifugation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Liu, Jennifer</creatorcontrib><creatorcontrib>Eris, Tamer</creatorcontrib><creatorcontrib>Li, Cynthia</creatorcontrib><creatorcontrib>Cao, Shawn</creatorcontrib><creatorcontrib>Kuhns, Scott</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Docstoc</collection><collection>Immunology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Biological Science Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>Biotechnology Research Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Liu, Jennifer</au><au>Eris, Tamer</au><au>Li, Cynthia</au><au>Cao, Shawn</au><au>Kuhns, Scott</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Assessing Analytical Similarity of Proposed Amgen Biosimilar ABP 501 to Adalimumab</atitle><jtitle>BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy</jtitle><stitle>BioDrugs</stitle><addtitle>BioDrugs</addtitle><date>2016-08-01</date><risdate>2016</risdate><volume>30</volume><issue>4</issue><spage>321</spage><epage>338</epage><pages>321-338</pages><issn>1173-8804</issn><eissn>1179-190X</eissn><abstract>Background
ABP 501 is being developed as a biosimilar to adalimumab. Comprehensive comparative analytical characterization studies have been conducted and completed.
Objective
The objective of this study was to assess analytical similarity between ABP 501 and two adalimumab reference products (RPs), licensed by the United States Food and Drug Administration (adalimumab [US]) and authorized by the European Union (adalimumab [EU]), using state-of-the-art analytical methods.
Methods
Comprehensive analytical characterization incorporating orthogonal analytical techniques was used to compare products. Physicochemical property comparisons comprised the primary structure related to amino acid sequence and post-translational modifications including glycans; higher-order structure; primary biological properties mediated by target and receptor binding; product-related substances and impurities; host-cell impurities; general properties of the finished drug product, including strength and formulation; subvisible and submicron particles and aggregates; and forced thermal degradation.
Results
ABP 501 had the same amino acid sequence and similar post-translational modification profiles compared with adalimumab RPs. Primary structure, higher-order structure, and biological activities were similar for the three products. Product-related size and charge variants and aggregate and particle levels were also similar. ABP 501 had very low residual host-cell protein and DNA. The finished ABP 501 drug product has the same strength with regard to protein concentration and fill volume as adalimumab RPs. ABP 501 and the RPs had a similar stability profile both in normal storage and thermal stress conditions.
Conclusion
Based on the comprehensive analytical similarity assessment, ABP 501 was found to be similar to adalimumab with respect to physicochemical and biological properties.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>27461107</pmid><doi>10.1007/s40259-016-0184-3</doi><tpages>18</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy, 2016-08, Vol.30 (4), p.321-338 |
| issn | 1173-8804 1179-190X |
| language | eng |
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| source | MEDLINE; SpringerLink Journals |
| subjects | Adalimumab - chemistry Adalimumab - pharmacology Animals Antibodies Arthritis Biological products Biomedical and Life Sciences Biomedicine Biosimilar Pharmaceuticals - analysis Biosimilar Pharmaceuticals - chemistry Biosimilar Pharmaceuticals - pharmacology Calorimetry, Differential Scanning Cancer Research CHO Cells - drug effects Chromatography Chromatography, High Pressure Liquid - methods Circular Dichroism Cricetulus Drug Stability Dynamic Light Scattering Electrophoresis, Capillary - methods Information services Isoelectric Point Manufacturing Molecular Medicine Original Original Research Article Peptide Mapping Peptides Pharmaceutical industry Pharmacotherapy Product development Quality Spectroscopy, Fourier Transform Infrared Technical communication Tumor necrosis factor-TNF Ultracentrifugation |
| title | Assessing Analytical Similarity of Proposed Amgen Biosimilar ABP 501 to Adalimumab |
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