Loading…
Update on Biosimilar Insulins: A US Perspective
The development of biosimilar insulin products has slowly evolved with only two follow-on biologics currently available to patients in the US. Both Basaglar ® (insulin glargine) and Admelog ® (insulin lispro) have undergone extensive testing, and have gained significant use by patients in the US. De...
Saved in:
| Published in: | BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy biopharmaceuticals, and gene therapy, 2020-08, Vol.34 (4), p.505-512 |
|---|---|
| Main Authors: | , , |
| Format: | Article |
| Language: | English |
| Subjects: | |
| Citations: | Items that this one cites Items that cite this one |
| Online Access: | Get full text |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| cited_by | cdi_FETCH-LOGICAL-c474t-a3e44015238a2411ac92d3d76785291ce7f8cfec532c89f4a36bddde2f40869b3 |
|---|---|
| cites | cdi_FETCH-LOGICAL-c474t-a3e44015238a2411ac92d3d76785291ce7f8cfec532c89f4a36bddde2f40869b3 |
| container_end_page | 512 |
| container_issue | 4 |
| container_start_page | 505 |
| container_title | BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy |
| container_volume | 34 |
| creator | Zhang, Rong M. Puri, Ritika McGill, Janet B. |
| description | The development of biosimilar insulin products has slowly evolved with only two follow-on biologics currently available to patients in the US. Both Basaglar
®
(insulin glargine) and Admelog
®
(insulin lispro) have undergone extensive testing, and have gained significant use by patients in the US. Despite the availability of these follow-on products, the price of insulin has remained stubbornly high. New regulatory guidance under the Biologics Price Competition and Innovations Act that came into effect in March 2020 introduced an abbreviated pathway for the approval of biosimilar insulins and introduced the option to apply for interchangeability of the biosimilar insulin with the reference product. This abbreviated clinical testing may open the doors for numerous follow-on insulin products, with unknown supply-chain and fiscal ramifications. This review will highlight the development process of biosimilar insulin in the US and the recent regulatory changes that can aid this process. We will also discuss challenges for prescribers and patients who are navigating this ever-changing landscape. These new regulations for biosimilar insulins will have ramifications for patients, healthcare providers, and third-party payers, though the direction and scope of these changes is unclear. |
| doi_str_mv | 10.1007/s40259-020-00431-0 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9262161</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2431842199</sourcerecordid><originalsourceid>FETCH-LOGICAL-c474t-a3e44015238a2411ac92d3d76785291ce7f8cfec532c89f4a36bddde2f40869b3</originalsourceid><addsrcrecordid>eNp9kU1Lw0AQhhdRbK3-AQ8S8OIldvYjya4HoRY_CgUFLXhbtptN3ZImdTcp-O9Nm1o_Dp5mYZ55Z4cHoVMMlxgg6XsGJBIhEAgBGMUh7KEuxokIsYDX_c2bhpwD66Aj7-cAEFORHKIOJTHHjERd1J8sU1WZoCyCG1t6u7C5csGo8HVuC38VDILJc_BknF8aXdmVOUYHmcq9OdnWHprc3b4MH8Lx4_1oOBiHmiWsChU1jAGOCOWKMIyVFiSlaRInPCICa5NkXGdGR5RoLjKmaDxN09SQjAGPxZT20HWbu6ynC5NqU1RO5XLp7EK5D1kqK393CvsmZ-VKChITHOMm4GIb4Mr32vhKLqzXJs9VYcraS8IIEyISbI2e_0HnZe2K5ryGopgzgoVoKNJS2pXeO5PtPoNBrn3I1odsfMiNDwnN0NnPM3YjXwIagLaAb1rFzLjv3f_EfgKR_JRx</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2431842199</pqid></control><display><type>article</type><title>Update on Biosimilar Insulins: A US Perspective</title><source>Springer Link</source><creator>Zhang, Rong M. ; Puri, Ritika ; McGill, Janet B.</creator><creatorcontrib>Zhang, Rong M. ; Puri, Ritika ; McGill, Janet B.</creatorcontrib><description>The development of biosimilar insulin products has slowly evolved with only two follow-on biologics currently available to patients in the US. Both Basaglar
®
(insulin glargine) and Admelog
®
(insulin lispro) have undergone extensive testing, and have gained significant use by patients in the US. Despite the availability of these follow-on products, the price of insulin has remained stubbornly high. New regulatory guidance under the Biologics Price Competition and Innovations Act that came into effect in March 2020 introduced an abbreviated pathway for the approval of biosimilar insulins and introduced the option to apply for interchangeability of the biosimilar insulin with the reference product. This abbreviated clinical testing may open the doors for numerous follow-on insulin products, with unknown supply-chain and fiscal ramifications. This review will highlight the development process of biosimilar insulin in the US and the recent regulatory changes that can aid this process. We will also discuss challenges for prescribers and patients who are navigating this ever-changing landscape. These new regulations for biosimilar insulins will have ramifications for patients, healthcare providers, and third-party payers, though the direction and scope of these changes is unclear.</description><identifier>ISSN: 1173-8804</identifier><identifier>EISSN: 1179-190X</identifier><identifier>DOI: 10.1007/s40259-020-00431-0</identifier><identifier>PMID: 32681425</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Antibodies ; Biological products ; Biomedical and Life Sciences ; Biomedicine ; Biosimilar Pharmaceuticals ; Cancer Research ; Clinical trials ; Diabetes ; Drug Approval ; Drug dosages ; FDA approval ; Generic drugs ; Humans ; Hypoglycemic Agents - metabolism ; Hypoglycemic Agents - therapeutic use ; Insulin ; Insulin - chemistry ; Insulin - metabolism ; Insulin Glargine - chemistry ; Insulin Glargine - metabolism ; Insulins ; Manufacturing ; Molecular Medicine ; Patient Protection & Affordable Care Act 2010-US ; Patient safety ; Pharmaceutical industry ; Pharmacokinetics ; Pharmacotherapy ; Pharmacy ; Review Article ; United States</subject><ispartof>BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy, 2020-08, Vol.34 (4), p.505-512</ispartof><rights>Springer Nature Switzerland AG 2020</rights><rights>Copyright Springer Nature B.V. Aug 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c474t-a3e44015238a2411ac92d3d76785291ce7f8cfec532c89f4a36bddde2f40869b3</citedby><cites>FETCH-LOGICAL-c474t-a3e44015238a2411ac92d3d76785291ce7f8cfec532c89f4a36bddde2f40869b3</cites><orcidid>0000-0002-6228-6521</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,315,786,790,891,27957,27958</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32681425$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zhang, Rong M.</creatorcontrib><creatorcontrib>Puri, Ritika</creatorcontrib><creatorcontrib>McGill, Janet B.</creatorcontrib><title>Update on Biosimilar Insulins: A US Perspective</title><title>BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy</title><addtitle>BioDrugs</addtitle><addtitle>BioDrugs</addtitle><description>The development of biosimilar insulin products has slowly evolved with only two follow-on biologics currently available to patients in the US. Both Basaglar
®
(insulin glargine) and Admelog
®
(insulin lispro) have undergone extensive testing, and have gained significant use by patients in the US. Despite the availability of these follow-on products, the price of insulin has remained stubbornly high. New regulatory guidance under the Biologics Price Competition and Innovations Act that came into effect in March 2020 introduced an abbreviated pathway for the approval of biosimilar insulins and introduced the option to apply for interchangeability of the biosimilar insulin with the reference product. This abbreviated clinical testing may open the doors for numerous follow-on insulin products, with unknown supply-chain and fiscal ramifications. This review will highlight the development process of biosimilar insulin in the US and the recent regulatory changes that can aid this process. We will also discuss challenges for prescribers and patients who are navigating this ever-changing landscape. These new regulations for biosimilar insulins will have ramifications for patients, healthcare providers, and third-party payers, though the direction and scope of these changes is unclear.</description><subject>Antibodies</subject><subject>Biological products</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Biosimilar Pharmaceuticals</subject><subject>Cancer Research</subject><subject>Clinical trials</subject><subject>Diabetes</subject><subject>Drug Approval</subject><subject>Drug dosages</subject><subject>FDA approval</subject><subject>Generic drugs</subject><subject>Humans</subject><subject>Hypoglycemic Agents - metabolism</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Insulin</subject><subject>Insulin - chemistry</subject><subject>Insulin - metabolism</subject><subject>Insulin Glargine - chemistry</subject><subject>Insulin Glargine - metabolism</subject><subject>Insulins</subject><subject>Manufacturing</subject><subject>Molecular Medicine</subject><subject>Patient Protection & Affordable Care Act 2010-US</subject><subject>Patient safety</subject><subject>Pharmaceutical industry</subject><subject>Pharmacokinetics</subject><subject>Pharmacotherapy</subject><subject>Pharmacy</subject><subject>Review Article</subject><subject>United States</subject><issn>1173-8804</issn><issn>1179-190X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp9kU1Lw0AQhhdRbK3-AQ8S8OIldvYjya4HoRY_CgUFLXhbtptN3ZImdTcp-O9Nm1o_Dp5mYZ55Z4cHoVMMlxgg6XsGJBIhEAgBGMUh7KEuxokIsYDX_c2bhpwD66Aj7-cAEFORHKIOJTHHjERd1J8sU1WZoCyCG1t6u7C5csGo8HVuC38VDILJc_BknF8aXdmVOUYHmcq9OdnWHprc3b4MH8Lx4_1oOBiHmiWsChU1jAGOCOWKMIyVFiSlaRInPCICa5NkXGdGR5RoLjKmaDxN09SQjAGPxZT20HWbu6ynC5NqU1RO5XLp7EK5D1kqK393CvsmZ-VKChITHOMm4GIb4Mr32vhKLqzXJs9VYcraS8IIEyISbI2e_0HnZe2K5ryGopgzgoVoKNJS2pXeO5PtPoNBrn3I1odsfMiNDwnN0NnPM3YjXwIagLaAb1rFzLjv3f_EfgKR_JRx</recordid><startdate>20200801</startdate><enddate>20200801</enddate><creator>Zhang, Rong M.</creator><creator>Puri, Ritika</creator><creator>McGill, Janet B.</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><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>5PM</scope><orcidid>https://orcid.org/0000-0002-6228-6521</orcidid></search><sort><creationdate>20200801</creationdate><title>Update on Biosimilar Insulins: A US Perspective</title><author>Zhang, Rong M. ; Puri, Ritika ; McGill, Janet B.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c474t-a3e44015238a2411ac92d3d76785291ce7f8cfec532c89f4a36bddde2f40869b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Antibodies</topic><topic>Biological products</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Biosimilar Pharmaceuticals</topic><topic>Cancer Research</topic><topic>Clinical trials</topic><topic>Diabetes</topic><topic>Drug Approval</topic><topic>Drug dosages</topic><topic>FDA approval</topic><topic>Generic drugs</topic><topic>Humans</topic><topic>Hypoglycemic Agents - metabolism</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Insulin</topic><topic>Insulin - chemistry</topic><topic>Insulin - metabolism</topic><topic>Insulin Glargine - chemistry</topic><topic>Insulin Glargine - metabolism</topic><topic>Insulins</topic><topic>Manufacturing</topic><topic>Molecular Medicine</topic><topic>Patient Protection & Affordable Care Act 2010-US</topic><topic>Patient safety</topic><topic>Pharmaceutical industry</topic><topic>Pharmacokinetics</topic><topic>Pharmacotherapy</topic><topic>Pharmacy</topic><topic>Review Article</topic><topic>United States</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zhang, Rong M.</creatorcontrib><creatorcontrib>Puri, Ritika</creatorcontrib><creatorcontrib>McGill, Janet B.</creatorcontrib><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 (ProQuest Medical & Health Databases)</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)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>ProQuest 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>Biological Sciences</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</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>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>Zhang, Rong M.</au><au>Puri, Ritika</au><au>McGill, Janet B.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Update on Biosimilar Insulins: A US Perspective</atitle><jtitle>BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy</jtitle><stitle>BioDrugs</stitle><addtitle>BioDrugs</addtitle><date>2020-08-01</date><risdate>2020</risdate><volume>34</volume><issue>4</issue><spage>505</spage><epage>512</epage><pages>505-512</pages><issn>1173-8804</issn><eissn>1179-190X</eissn><notes>ObjectType-Article-2</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-3</notes><notes>content type line 23</notes><notes>ObjectType-Review-1</notes><abstract>The development of biosimilar insulin products has slowly evolved with only two follow-on biologics currently available to patients in the US. Both Basaglar
®
(insulin glargine) and Admelog
®
(insulin lispro) have undergone extensive testing, and have gained significant use by patients in the US. Despite the availability of these follow-on products, the price of insulin has remained stubbornly high. New regulatory guidance under the Biologics Price Competition and Innovations Act that came into effect in March 2020 introduced an abbreviated pathway for the approval of biosimilar insulins and introduced the option to apply for interchangeability of the biosimilar insulin with the reference product. This abbreviated clinical testing may open the doors for numerous follow-on insulin products, with unknown supply-chain and fiscal ramifications. This review will highlight the development process of biosimilar insulin in the US and the recent regulatory changes that can aid this process. We will also discuss challenges for prescribers and patients who are navigating this ever-changing landscape. These new regulations for biosimilar insulins will have ramifications for patients, healthcare providers, and third-party payers, though the direction and scope of these changes is unclear.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>32681425</pmid><doi>10.1007/s40259-020-00431-0</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-6228-6521</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1173-8804 |
| ispartof | BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy, 2020-08, Vol.34 (4), p.505-512 |
| issn | 1173-8804 1179-190X |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9262161 |
| source | Springer Link |
| subjects | Antibodies Biological products Biomedical and Life Sciences Biomedicine Biosimilar Pharmaceuticals Cancer Research Clinical trials Diabetes Drug Approval Drug dosages FDA approval Generic drugs Humans Hypoglycemic Agents - metabolism Hypoglycemic Agents - therapeutic use Insulin Insulin - chemistry Insulin - metabolism Insulin Glargine - chemistry Insulin Glargine - metabolism Insulins Manufacturing Molecular Medicine Patient Protection & Affordable Care Act 2010-US Patient safety Pharmaceutical industry Pharmacokinetics Pharmacotherapy Pharmacy Review Article United States |
| title | Update on Biosimilar Insulins: A US Perspective |
| url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-09-23T04%3A24%3A53IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Update%20on%20Biosimilar%20Insulins:%20A%20US%20Perspective&rft.jtitle=BioDrugs%20:%20clinical%20immunotherapeutics,%20biopharmaceuticals,%20and%20gene%20therapy&rft.au=Zhang,%20Rong%20M.&rft.date=2020-08-01&rft.volume=34&rft.issue=4&rft.spage=505&rft.epage=512&rft.pages=505-512&rft.issn=1173-8804&rft.eissn=1179-190X&rft_id=info:doi/10.1007/s40259-020-00431-0&rft_dat=%3Cproquest_pubme%3E2431842199%3C/proquest_pubme%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c474t-a3e44015238a2411ac92d3d76785291ce7f8cfec532c89f4a36bddde2f40869b3%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=2431842199&rft_id=info:pmid/32681425&rfr_iscdi=true |