LBEC0101, A Proposed Etanercept Biosimilar: Pharmacokinetics, Immunogenicity, and Tolerability Profiles Compared with a Reference Biologic Product in Healthy Male Subjects
Objectives We performed this study to compare the pharmacokinetic (PK), immunogenicity, and tolerability profiles of etanercept between LBEC0101, a proposed biosimilar, and Enbrel ® , the reference biological product. Methods A randomized, double-blind, single-dose, two-treatment, two-period, two-se...
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| Veröffentlicht in: | BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy biopharmaceuticals, and gene therapy, 2017-08, Vol.31 (4), p.349-355 |
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| container_title | BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy |
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| creator | Lee, Heechan Chung, Hyewon Lee, SeungHwan Lee, Howard Yang, Sung Mo Yoon, Seo Hyun Cho, Joo-Youn Jang, In-Jin Yu, Kyung-Sang |
| description | Objectives
We performed this study to compare the pharmacokinetic (PK), immunogenicity, and tolerability profiles of etanercept between LBEC0101, a proposed biosimilar, and Enbrel
®
, the reference biological product.
Methods
A randomized, double-blind, single-dose, two-treatment, two-period, two-sequence, crossover study was conducted in 48 healthy males. In each period, a single dose of LBEC0101 or Enbrel
®
was subcutaneously injected at 25 mg and serial blood samples for PK evaluation were collected up to 648 h post-dose. Serum etanercept concentrations and anti-drug antibodies (ADA) were measured using an enzyme-linked immunosorbent assay and an affinity capture elution assay. Log-transformed maximum concentration (
C
max
) and area under the concentration–time curve (AUC
inf
) were compared. Tolerability was also evaluated.
Results
The serum concentration–time profiles were almost overlapped between LBEC0101 and Enbrel
®
. Geometric mean ratio (90% confidence intervals) for
C
max
and AUC
inf
of LBEC0101 to Enbrel
®
were 1.02 (0.92–1.13) and 0.96 (0.87–1.05), respectively, which were within a conventional bioequivalence criteria of 0.80–1.25. ADA development was also comparable. Both drugs were well tolerated.
Conclusions
LBEC0101 showed similar PK, immunogenicity, and tolerability profiles to Enbrel
®
after a single subcutaneous injection in healthy males. LBEC0101 can be further developed as a potential etanercept biosimilar (ClinicalTrial.gov identifier: NCT01725620). |
| doi_str_mv | 10.1007/s40259-017-0230-9 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1903438078</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1903438078</sourcerecordid><originalsourceid>FETCH-LOGICAL-c372t-91bd238c04530815412f419e0614bf221f7d73a354ce4f91cf79312b4c6080ae3</originalsourceid><addsrcrecordid>eNp1kc9u1DAQhyMEon_gAbggS1w4bGAcO-uYW7va0kqLqKBI3CLHmex6ceLUdoT2mXhJHLYghMTJlv3NN6P5ZdkLCm8ogHgbOBSlzIGKHAoGuXyUnVIqZE4lfH38687yqgJ-kp2FsAeAJZPiaXZSVGVJhShPsx-by_UKKNAFuSC33o0uYEvWUQ3oNY6RXBoXTG-s8u_I7U75Xmn3zQwYjQ4LctP30-C2OBht4mFB1NCSO2fRq8bY9DIrO2MxkJXrR-WT-7uJO6LIJ-zQ46Bx7mDd1uiZbScdiRnINSobdwfyQVkkn6dmjzqGZ9mTTtmAzx_O8-zL1fpudZ1vPr6_WV1scs1EEXNJm7ZglQZeMqhoyWnRcSoRlpQ3XVHQTrSCKVZyjbyTVHdCMlo0XC-hAoXsPHt99I7e3U8YYt2boNHatBQ3hTptl3FWgagS-uofdO8mP6TpEiWY4Ay4TBQ9Utq7EDx29ehNr_yhplDPSdbHJOuUZD0nWc81Lx_MU9Nj-6fid3QJKI5ASF_DFv1frf9r_Qn8B6jK</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1973743049</pqid></control><display><type>article</type><title>LBEC0101, A Proposed Etanercept Biosimilar: Pharmacokinetics, Immunogenicity, and Tolerability Profiles Compared with a Reference Biologic Product in Healthy Male Subjects</title><source>Springer Nature - Complete Springer Journals</source><creator>Lee, Heechan ; Chung, Hyewon ; Lee, SeungHwan ; Lee, Howard ; Yang, Sung Mo ; Yoon, Seo Hyun ; Cho, Joo-Youn ; Jang, In-Jin ; Yu, Kyung-Sang</creator><creatorcontrib>Lee, Heechan ; Chung, Hyewon ; Lee, SeungHwan ; Lee, Howard ; Yang, Sung Mo ; Yoon, Seo Hyun ; Cho, Joo-Youn ; Jang, In-Jin ; Yu, Kyung-Sang</creatorcontrib><description>Objectives
We performed this study to compare the pharmacokinetic (PK), immunogenicity, and tolerability profiles of etanercept between LBEC0101, a proposed biosimilar, and Enbrel
®
, the reference biological product.
Methods
A randomized, double-blind, single-dose, two-treatment, two-period, two-sequence, crossover study was conducted in 48 healthy males. In each period, a single dose of LBEC0101 or Enbrel
®
was subcutaneously injected at 25 mg and serial blood samples for PK evaluation were collected up to 648 h post-dose. Serum etanercept concentrations and anti-drug antibodies (ADA) were measured using an enzyme-linked immunosorbent assay and an affinity capture elution assay. Log-transformed maximum concentration (
C
max
) and area under the concentration–time curve (AUC
inf
) were compared. Tolerability was also evaluated.
Results
The serum concentration–time profiles were almost overlapped between LBEC0101 and Enbrel
®
. Geometric mean ratio (90% confidence intervals) for
C
max
and AUC
inf
of LBEC0101 to Enbrel
®
were 1.02 (0.92–1.13) and 0.96 (0.87–1.05), respectively, which were within a conventional bioequivalence criteria of 0.80–1.25. ADA development was also comparable. Both drugs were well tolerated.
Conclusions
LBEC0101 showed similar PK, immunogenicity, and tolerability profiles to Enbrel
®
after a single subcutaneous injection in healthy males. LBEC0101 can be further developed as a potential etanercept biosimilar (ClinicalTrial.gov identifier: NCT01725620).</description><identifier>ISSN: 1173-8804</identifier><identifier>EISSN: 1179-190X</identifier><identifier>DOI: 10.1007/s40259-017-0230-9</identifier><identifier>PMID: 28551775</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Alcohol ; Antibodies ; Autoimmune diseases ; Biological products ; Biomedical and Life Sciences ; Biomedicine ; Body mass index ; Cancer Research ; Drug development ; Drug dosages ; Elution ; Enzyme-linked immunosorbent assay ; Enzymes ; Etanercept ; Family medical history ; FDA approval ; Food ; Immunogenicity ; Life sciences ; Males ; Molecular Medicine ; Original Research Article ; Pharmaceutical industry ; Pharmacokinetics ; Pharmacotherapy ; Product safety ; Psoriasis ; Rheumatoid arthritis ; Studies ; Tuberculosis ; Tumor necrosis factor-TNF</subject><ispartof>BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy, 2017-08, Vol.31 (4), p.349-355</ispartof><rights>Springer International Publishing Switzerland 2017</rights><rights>Copyright Springer Science & Business Media Aug 2017</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c372t-91bd238c04530815412f419e0614bf221f7d73a354ce4f91cf79312b4c6080ae3</citedby><cites>FETCH-LOGICAL-c372t-91bd238c04530815412f419e0614bf221f7d73a354ce4f91cf79312b4c6080ae3</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/s40259-017-0230-9$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s40259-017-0230-9$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28551775$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lee, Heechan</creatorcontrib><creatorcontrib>Chung, Hyewon</creatorcontrib><creatorcontrib>Lee, SeungHwan</creatorcontrib><creatorcontrib>Lee, Howard</creatorcontrib><creatorcontrib>Yang, Sung Mo</creatorcontrib><creatorcontrib>Yoon, Seo Hyun</creatorcontrib><creatorcontrib>Cho, Joo-Youn</creatorcontrib><creatorcontrib>Jang, In-Jin</creatorcontrib><creatorcontrib>Yu, Kyung-Sang</creatorcontrib><title>LBEC0101, A Proposed Etanercept Biosimilar: Pharmacokinetics, Immunogenicity, and Tolerability Profiles Compared with a Reference Biologic Product in Healthy Male Subjects</title><title>BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy</title><addtitle>BioDrugs</addtitle><addtitle>BioDrugs</addtitle><description>Objectives
We performed this study to compare the pharmacokinetic (PK), immunogenicity, and tolerability profiles of etanercept between LBEC0101, a proposed biosimilar, and Enbrel
®
, the reference biological product.
Methods
A randomized, double-blind, single-dose, two-treatment, two-period, two-sequence, crossover study was conducted in 48 healthy males. In each period, a single dose of LBEC0101 or Enbrel
®
was subcutaneously injected at 25 mg and serial blood samples for PK evaluation were collected up to 648 h post-dose. Serum etanercept concentrations and anti-drug antibodies (ADA) were measured using an enzyme-linked immunosorbent assay and an affinity capture elution assay. Log-transformed maximum concentration (
C
max
) and area under the concentration–time curve (AUC
inf
) were compared. Tolerability was also evaluated.
Results
The serum concentration–time profiles were almost overlapped between LBEC0101 and Enbrel
®
. Geometric mean ratio (90% confidence intervals) for
C
max
and AUC
inf
of LBEC0101 to Enbrel
®
were 1.02 (0.92–1.13) and 0.96 (0.87–1.05), respectively, which were within a conventional bioequivalence criteria of 0.80–1.25. ADA development was also comparable. Both drugs were well tolerated.
Conclusions
LBEC0101 showed similar PK, immunogenicity, and tolerability profiles to Enbrel
®
after a single subcutaneous injection in healthy males. LBEC0101 can be further developed as a potential etanercept biosimilar (ClinicalTrial.gov identifier: NCT01725620).</description><subject>Alcohol</subject><subject>Antibodies</subject><subject>Autoimmune diseases</subject><subject>Biological products</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Body mass index</subject><subject>Cancer Research</subject><subject>Drug development</subject><subject>Drug dosages</subject><subject>Elution</subject><subject>Enzyme-linked immunosorbent assay</subject><subject>Enzymes</subject><subject>Etanercept</subject><subject>Family medical history</subject><subject>FDA approval</subject><subject>Food</subject><subject>Immunogenicity</subject><subject>Life sciences</subject><subject>Males</subject><subject>Molecular Medicine</subject><subject>Original Research Article</subject><subject>Pharmaceutical industry</subject><subject>Pharmacokinetics</subject><subject>Pharmacotherapy</subject><subject>Product safety</subject><subject>Psoriasis</subject><subject>Rheumatoid arthritis</subject><subject>Studies</subject><subject>Tuberculosis</subject><subject>Tumor necrosis factor-TNF</subject><issn>1173-8804</issn><issn>1179-190X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>BENPR</sourceid><recordid>eNp1kc9u1DAQhyMEon_gAbggS1w4bGAcO-uYW7va0kqLqKBI3CLHmex6ceLUdoT2mXhJHLYghMTJlv3NN6P5ZdkLCm8ogHgbOBSlzIGKHAoGuXyUnVIqZE4lfH38687yqgJ-kp2FsAeAJZPiaXZSVGVJhShPsx-by_UKKNAFuSC33o0uYEvWUQ3oNY6RXBoXTG-s8u_I7U75Xmn3zQwYjQ4LctP30-C2OBht4mFB1NCSO2fRq8bY9DIrO2MxkJXrR-WT-7uJO6LIJ-zQ46Bx7mDd1uiZbScdiRnINSobdwfyQVkkn6dmjzqGZ9mTTtmAzx_O8-zL1fpudZ1vPr6_WV1scs1EEXNJm7ZglQZeMqhoyWnRcSoRlpQ3XVHQTrSCKVZyjbyTVHdCMlo0XC-hAoXsPHt99I7e3U8YYt2boNHatBQ3hTptl3FWgagS-uofdO8mP6TpEiWY4Ay4TBQ9Utq7EDx29ehNr_yhplDPSdbHJOuUZD0nWc81Lx_MU9Nj-6fid3QJKI5ASF_DFv1frf9r_Qn8B6jK</recordid><startdate>20170801</startdate><enddate>20170801</enddate><creator>Lee, Heechan</creator><creator>Chung, Hyewon</creator><creator>Lee, SeungHwan</creator><creator>Lee, Howard</creator><creator>Yang, Sung Mo</creator><creator>Yoon, Seo Hyun</creator><creator>Cho, Joo-Youn</creator><creator>Jang, In-Jin</creator><creator>Yu, Kyung-Sang</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><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>PHGZM</scope><scope>PHGZT</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQGLB</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20170801</creationdate><title>LBEC0101, A Proposed Etanercept Biosimilar: Pharmacokinetics, Immunogenicity, and Tolerability Profiles Compared with a Reference Biologic Product in Healthy Male Subjects</title><author>Lee, Heechan ; Chung, Hyewon ; Lee, SeungHwan ; Lee, Howard ; Yang, Sung Mo ; Yoon, Seo Hyun ; Cho, Joo-Youn ; Jang, In-Jin ; Yu, Kyung-Sang</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c372t-91bd238c04530815412f419e0614bf221f7d73a354ce4f91cf79312b4c6080ae3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Alcohol</topic><topic>Antibodies</topic><topic>Autoimmune diseases</topic><topic>Biological products</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Body mass index</topic><topic>Cancer Research</topic><topic>Drug development</topic><topic>Drug dosages</topic><topic>Elution</topic><topic>Enzyme-linked immunosorbent assay</topic><topic>Enzymes</topic><topic>Etanercept</topic><topic>Family medical history</topic><topic>FDA approval</topic><topic>Food</topic><topic>Immunogenicity</topic><topic>Life sciences</topic><topic>Males</topic><topic>Molecular Medicine</topic><topic>Original Research Article</topic><topic>Pharmaceutical industry</topic><topic>Pharmacokinetics</topic><topic>Pharmacotherapy</topic><topic>Product safety</topic><topic>Psoriasis</topic><topic>Rheumatoid arthritis</topic><topic>Studies</topic><topic>Tuberculosis</topic><topic>Tumor necrosis factor-TNF</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lee, Heechan</creatorcontrib><creatorcontrib>Chung, Hyewon</creatorcontrib><creatorcontrib>Lee, SeungHwan</creatorcontrib><creatorcontrib>Lee, Howard</creatorcontrib><creatorcontrib>Yang, Sung Mo</creatorcontrib><creatorcontrib>Yoon, Seo Hyun</creatorcontrib><creatorcontrib>Cho, Joo-Youn</creatorcontrib><creatorcontrib>Jang, In-Jin</creatorcontrib><creatorcontrib>Yu, Kyung-Sang</creatorcontrib><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 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(New)</collection><collection>ProQuest One Health & Nursing</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Applied & Life Sciences</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lee, Heechan</au><au>Chung, Hyewon</au><au>Lee, SeungHwan</au><au>Lee, Howard</au><au>Yang, Sung Mo</au><au>Yoon, Seo Hyun</au><au>Cho, Joo-Youn</au><au>Jang, In-Jin</au><au>Yu, Kyung-Sang</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>LBEC0101, A Proposed Etanercept Biosimilar: Pharmacokinetics, Immunogenicity, and Tolerability Profiles Compared with a Reference Biologic Product in Healthy Male Subjects</atitle><jtitle>BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy</jtitle><stitle>BioDrugs</stitle><addtitle>BioDrugs</addtitle><date>2017-08-01</date><risdate>2017</risdate><volume>31</volume><issue>4</issue><spage>349</spage><epage>355</epage><pages>349-355</pages><issn>1173-8804</issn><eissn>1179-190X</eissn><abstract>Objectives
We performed this study to compare the pharmacokinetic (PK), immunogenicity, and tolerability profiles of etanercept between LBEC0101, a proposed biosimilar, and Enbrel
®
, the reference biological product.
Methods
A randomized, double-blind, single-dose, two-treatment, two-period, two-sequence, crossover study was conducted in 48 healthy males. In each period, a single dose of LBEC0101 or Enbrel
®
was subcutaneously injected at 25 mg and serial blood samples for PK evaluation were collected up to 648 h post-dose. Serum etanercept concentrations and anti-drug antibodies (ADA) were measured using an enzyme-linked immunosorbent assay and an affinity capture elution assay. Log-transformed maximum concentration (
C
max
) and area under the concentration–time curve (AUC
inf
) were compared. Tolerability was also evaluated.
Results
The serum concentration–time profiles were almost overlapped between LBEC0101 and Enbrel
®
. Geometric mean ratio (90% confidence intervals) for
C
max
and AUC
inf
of LBEC0101 to Enbrel
®
were 1.02 (0.92–1.13) and 0.96 (0.87–1.05), respectively, which were within a conventional bioequivalence criteria of 0.80–1.25. ADA development was also comparable. Both drugs were well tolerated.
Conclusions
LBEC0101 showed similar PK, immunogenicity, and tolerability profiles to Enbrel
®
after a single subcutaneous injection in healthy males. LBEC0101 can be further developed as a potential etanercept biosimilar (ClinicalTrial.gov identifier: NCT01725620).</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>28551775</pmid><doi>10.1007/s40259-017-0230-9</doi><tpages>7</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1173-8804 |
| ispartof | BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy, 2017-08, Vol.31 (4), p.349-355 |
| issn | 1173-8804 1179-190X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1903438078 |
| source | Springer Nature - Complete Springer Journals |
| subjects | Alcohol Antibodies Autoimmune diseases Biological products Biomedical and Life Sciences Biomedicine Body mass index Cancer Research Drug development Drug dosages Elution Enzyme-linked immunosorbent assay Enzymes Etanercept Family medical history FDA approval Food Immunogenicity Life sciences Males Molecular Medicine Original Research Article Pharmaceutical industry Pharmacokinetics Pharmacotherapy Product safety Psoriasis Rheumatoid arthritis Studies Tuberculosis Tumor necrosis factor-TNF |
| title | LBEC0101, A Proposed Etanercept Biosimilar: Pharmacokinetics, Immunogenicity, and Tolerability Profiles Compared with a Reference Biologic Product in Healthy Male Subjects |
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