| WHO informal consultation on regulatory evaluation of therapeutic biological medicinal products held at WHO Headquarters, Geneva, 19-20 April 2007. | |
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MedLine Citation:
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PMID: 18218324 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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This report reflects the discussion and conclusions of an informal consultation held on 19-20 April 2007 at the World Health Organization concerning the regulatory evaluation of therapeutic biological medicinal products. The objectives of this meeting were to discuss the current status of so-called "similar" biological medicinal products (biosimilars) and to review regulatory pathways and challenges in evaluating the quality, safety and efficacy of these products. Biosimilars are products that are subject to licensing with a reduced data package due to a proven 'similarity' to the licensed reference product. The meeting was attended by experts in biotherapeutics from regulatory agencies, industry and academia representing 16 countries worldwide. Dr. Elwyn Griffiths (Canada) acted as Chairman and Dr. James Robertson (UK) was the Rapporteur. The meeting strongly focused on the usage of biosimilars and the current regulatory situation in many different countries. The application of International Nonproprietary Names (INN) to biosimilars, their potential immunogenicity, and WHO international standards and reference materials were also discussed, alongside presentations from the innovator and generic manufacturing industries. The consultation recognized the importance of the terminology as well as a definition of biosimilars for future considerations of these products. However, achieving a global consensus on the terminology for these new challenging products was not attempted at the Consultation, and it was decided that a future WHO working group should act on this issue as a next step. For purposes of this meeting report only, the term 'biosimilars' is temporarily used to refer to this category of products. It became clear that biotherapeutics authorized on the basis of a reduced data package are available and being used in some countries, with more appearing on the market. The existence of divergent approaches to the regulatory oversight of biosimilars in different countries revealed a need for defining regulatory expectations for these products at the global level. While many countries are following the guideline developed within the EU for quality aspects, discrepancies remain regarding the non-clinical and clinical studies of these products. The Consultation recommended that the WHO should develop a guideline in this area in order to provide a framework for the development of regulatory pathways for these products worldwide. For this purpose, agreement on the scope, definition and terminology of these products was deemed necessary. The interchangeability and substitution of products were also flagged as areas in need of harmonization. A WHO working group should be established to develop a guideline that would promote global consensus on the regulation of biosimilars, assist in their registration and enhance the availability of safe and effective biosimilar products worldwide. |
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Authors:
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Jeewon Joung; James S Robertson; Elwyn Griffiths; Ivana Knezevic; |
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Publication Detail:
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Type: Congresses Date: 2008-01-22 |
Journal Detail:
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Title: Biologicals : journal of the International Association of Biological Standardization Volume: 36 ISSN: 1045-1056 ISO Abbreviation: Biologicals Publication Date: 2008 Jul |
Date Detail:
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Created Date: 2008-06-30 Completed Date: 2008-10-14 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9004494 Medline TA: Biologicals Country: England |
Other Details:
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Languages: eng Pagination: 269-76 Citation Subset: IM |
Affiliation:
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World Health Organization, Department of Immunization, Vaccines and Biologicals, Quality, Safety and Standards, 20 Avenue Appia, CH-1211 Geneva, Switzerland. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Biological Products
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therapeutic use* Chemistry, Pharmaceutical / legislation & jurisprudence* Erythropoietin / therapeutic use Humans Switzerland World Health Organization* |
| Chemical | |
Reg. No./Substance:
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0/Biological Products; 11096-26-7/Erythropoietin |
| Investigator | |
Investigator/Affiliation:
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Adrian Bristow / ; Elaine Gray / ; Robin Thorpe / ; James S Robertson / ; Majid Cheraghali / ; Laura Gomes Castanheira / ; Granville Garcia de Oliveira / ; Elwyn Griffiths / ; Kwasi Nyarko / ; Ulrich Kalinke / ; Toru Kawanishi / ; Teruhide Yamaguchi / ; Jean Christian Krayenbühl / ; Monika Schmid-Appert / ; Maria Poulis / ; Huub Schellekens / ; Yeowon Sohn / ; James Southern / ; Keith Webber / ; Martina Weise / ; Shri Parthajyoti Gogoi / ; Wang Junzhi / ; Peter Richardson / ; Sunil Gairola / ; Jacques Mascaro / ; Andrew Fox / ; Ryoko Krause / ; Martin Schiestl / ; Suzette Kox / ; Aliza Eshkol / ; Raffaella Balocco Mattavelli / ; Sophie Lasseur / ; Ji-Cui Dong / ; David Wood / ; Ivana Knezevic / ; Jeewon Joung / |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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