Please use this identifier to cite or link to this item: https://doi.org/10.3390/ph5040353
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dc.titleOn the regulatory approval pathway of biosimilar products
dc.contributor.authorWang, J
dc.contributor.authorChow, S.-C
dc.date.accessioned2020-10-27T04:55:45Z
dc.date.available2020-10-27T04:55:45Z
dc.date.issued2012
dc.identifier.citationWang, J, Chow, S.-C (2012). On the regulatory approval pathway of biosimilar products. Pharmaceuticals 5 (4) : 353-368. ScholarBank@NUS Repository. https://doi.org/10.3390/ph5040353
dc.identifier.issn1424-8247
dc.identifier.urihttps://scholarbank.nus.edu.sg/handle/10635/180841
dc.description.abstractBiosimilars (or follow-on biologics) are a new class of medicine which enters the market subsequent to a previously approved version. They have demonstrated similarity to innovator biologic products in terms of quality, safety, and efficacy. The EMA has taken the lead in the regulatory approval framework for biosimilar products, and WHO has published guidelines on the evaluation of biosimilars in order to facilitate the global harmonization. Based on EMA and WHO guidelines, many other countries such as Canada, Japan and Korea have also issued their own guidance for evaluating follow-on biologics. The US FDA was authorized to approve follow-on biologics by the BPCI Act passed by the US Congress on March 23, 2010, and has just issued a draft guidance in early 2012. The basic concepts and main principles of approving biosimilars are similar among various nations, notwithstanding some differences in regard to the scope, the choice of reference product, and the data requirement. This article reviews the regulatory approval pathway of biosimilar products in different regions. © 2012 by the authors; licensee MDPI, Basel, Switzerland.
dc.rightsAttribution 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourceUnpaywall 20201031
dc.subjectbiological product
dc.subjectbioequivalence
dc.subjectbiological activity
dc.subjectCanada
dc.subjectclinical evaluation
dc.subjectdrug approval
dc.subjectdrug efficacy
dc.subjectdrug manufacture
dc.subjectdrug purity
dc.subjectdrug quality
dc.subjectdrug research
dc.subjectdrug safety
dc.subjectdrug stability
dc.subjectEuropean Medicines Agency
dc.subjectEuropean Union
dc.subjectfood and drug administration
dc.subjectgovernment regulation
dc.subjectJapan
dc.subjectKorea
dc.subjectmedical society
dc.subjectorganization
dc.subjectpharmacodynamics
dc.subjectpharmacokinetics
dc.subjectphysical chemistry
dc.subjectpolitical participation
dc.subjectpractice guideline
dc.subjectreview
dc.subjectUnited States
dc.subjectworld health organization
dc.typeReview
dc.contributor.departmentDUKE-NUS MEDICAL SCHOOL
dc.description.doi10.3390/ph5040353
dc.description.sourcetitlePharmaceuticals
dc.description.volume5
dc.description.issue4
dc.description.page353-368
dc.published.statePublished
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