Controversies in Establishing Biosimilarity: Extrapolation of Indications and Global Labeling Practices
The principles of establishing biosimilarity are to demonstrate structural and functional similarity to a reference product using the most discriminatory analytical methods. There is still considerable controversy on the scientific basis for extrapolation of indications for biosimilars, which has be...
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| Published in: | BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy Vol. 30; no. 1; pp. 1 - 8 |
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| Main Authors: | , |
| Format: | Journal Article |
| Language: | English |
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Springer International Publishing
01-02-2016
Springer Nature B.V |
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| Abstract | The principles of establishing biosimilarity are to demonstrate structural and functional similarity to a reference product using the most discriminatory analytical methods. There is still considerable controversy on the scientific basis for extrapolation of indications for biosimilars, which has been strengthened by diverging global regulatory decision making. Closely related to the question of extrapolation is the question of how to communicate the evidence base for authorizing biosimilars to healthcare professionals. In this paper we will consider some of the discussions around extrapolation of indications and the implications of decisions of various regulatory agencies in the world regarding the authorization and labeling of biosimilars. |
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| AbstractList | The principles of establishing biosimilarity are to demonstrate structural and functional similarity to a reference product using the most discriminatory analytical methods. There is still considerable controversy on the scientific basis for extrapolation of indications for biosimilars, which has been strengthened by diverging global regulatory decision making. Closely related to the question of extrapolation is the question of how to communicate the evidence base for authorizing biosimilars to healthcare professionals. In this paper we will consider some of the discussions around extrapolation of indications and the implications of decisions of various regulatory agencies in the world regarding the authorization and labeling of biosimilars. |
| Author | Chamberlain, Paul Ebbers, Hans C. |
| Author_xml | – sequence: 1 givenname: Hans C. surname: Ebbers fullname: Ebbers, Hans C. organization: Department of Pharmaceutical Sciences, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht Centre of Excellence for Affordable Biotherapeutics for Public Health – sequence: 2 givenname: Paul surname: Chamberlain fullname: Chamberlain, Paul email: paul.chamberlain@ndareg.com organization: NDA Advisory Services Ltd, Prime House, Challenge Court |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/26758077$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1111/apt.12507 10.1001/jama.2011.406 10.5639/gabij.2015.0401.004 10.1093/rheumatology/keq031 10.4321/S1130-01082013000100006 10.1002/art.23447 10.1182/blood-2014-06-583617 10.1136/annrheumdis-2012-202941 10.1016/j.biologicals.2014.05.005 10.1038/nbt.3083 10.5639/gabij.2014.0304.043 10.1016/j.drudis.2013.05.004 10.1007/s00251-013-0679-8 10.1208/s12248-013-9534-y 10.1016/j.pharmthera.2007.10.001 10.1038/nbt.2447 10.1159/000356193 10.1111/j.1365-2036.2004.01871.x 10.4161/mabs.32221 10.1016/j.reumae.2012.11.003 10.1517/14712598.2015.1083552 10.1136/gutjnl-2013-305259 10.1111/1756-185X.12711 10.1136/gutjnl-2015-309290 10.1136/gutjnl-2014-307882 |
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| Keywords | Remicade Chronic Kidney Disease Reference Product Insulin Glargine Ankylose Spondylitis |
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| Title | Controversies in Establishing Biosimilarity: Extrapolation of Indications and Global Labeling Practices |
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