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- Biosimilar abstract "A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product which is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original \"innovator\" products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. Follow-on manufacturers do not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance. They do have access to the commercialized innovator product.Drug related authorities such as European Medicines Agency (EMA), Food and Drug Administration (FDA), and Health Canada hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy. According to them, analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components, animal studies (including the assessment of toxicity), and a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product.In case of a monoclonal antibody-containing medicinal product, such as Remsima, extensive physicochemical and biological characterization for it and its reference product Remicade was conducted in order to demonstrate their highly similar properties. Consequently, EMA have granted a marketing authorisation for only a few numbers of biosimilars since 2006 including a monoclonal antibody which is recently approved. Meanwhile, on March 6, 2015, the FDA approved the United States's first biosimilar product, the biosimilar filgrastim Zarzio by Sandoz.".
- Biosimilar wikiPageExternalLink thomas.loc.gov.
- Biosimilar wikiPageExternalLink whats-keeping-generic-version-biologic-drugs-u-s-market.
- Biosimilar wikiPageID "12924448".
- Biosimilar wikiPageLength "21012".
- Biosimilar wikiPageOutDegree "38".
- Biosimilar wikiPageRevisionID "704467158".
- Biosimilar wikiPageWikiLink Biopharmaceutical.
- Biosimilar wikiPageWikiLink Category:Biotechnology.
- Biosimilar wikiPageWikiLink Category:Drugs.
- Biosimilar wikiPageWikiLink Category:Life_sciences_industry.
- Biosimilar wikiPageWikiLink Cell_therapy.
- Biosimilar wikiPageWikiLink Chemical_patent.
- Biosimilar wikiPageWikiLink Erythropoietin.
- Biosimilar wikiPageWikiLink European_Medicines_Agency.
- Biosimilar wikiPageWikiLink Filgrastim.
- Biosimilar wikiPageWikiLink Food_and_Drug_Administration.
- Biosimilar wikiPageWikiLink Gene_therapy.
- Biosimilar wikiPageWikiLink Growth_hormone.
- Biosimilar wikiPageWikiLink Health_Products_and_Food_Branch.
- Biosimilar wikiPageWikiLink Infliximab.
- Biosimilar wikiPageWikiLink Insulin.
- Biosimilar wikiPageWikiLink Interferon.
- Biosimilar wikiPageWikiLink Monoclonal_antibody.
- Biosimilar wikiPageWikiLink Novartis.
- Biosimilar wikiPageWikiLink Patent_cliff.
- Biosimilar wikiPageWikiLink Patient_Protection_and_Affordable_Care_Act.
- Biosimilar wikiPageWikiLink Pharmacovigilance.
- Biosimilar wikiPageWikiLink Protein.
- Biosimilar wikiPageWikiLink Recombinant_DNA.
- Biosimilar wikiPageWikiLink Small_molecule.
- Biosimilar wikiPageWikiLink Ted_Kennedy.
- Biosimilar wikiPageWikiLink Test_data_exclusivity.
- Biosimilar wikiPageWikiLink United_States.
- Biosimilar wikiPageWikiLink File:Biosimilars_Patent_Cliff.png.
- Biosimilar wikiPageWikiLinkText "''similar biological medicinal products''".
- Biosimilar wikiPageWikiLinkText "Biosimilar".
- Biosimilar wikiPageWikiLinkText "biosimilar".
- Biosimilar date "September 2015".
- Biosimilar reason "There is no verb in this sentence.".
- Biosimilar wikiPageUsesTemplate Template:Cite_journal.
- Biosimilar wikiPageUsesTemplate Template:Clarify.
- Biosimilar wikiPageUsesTemplate Template:Open_access.
- Biosimilar wikiPageUsesTemplate Template:Reflist.
- Biosimilar subject Category:Biotechnology.
- Biosimilar subject Category:Drugs.
- Biosimilar subject Category:Life_sciences_industry.
- Biosimilar hypernym Product.
- Biosimilar type Drug.
- Biosimilar type Software.
- Biosimilar type Drug.
- Biosimilar comment "A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product which is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original \"innovator\" products, and can be manufactured when the original product's patent expires.".
- Biosimilar label "Biosimilar".
- Biosimilar sameAs Q864715.
- Biosimilar sameAs بدائل_حيوية.
- Biosimilar sameAs Biosimilar.
- Biosimilar sameAs Biosimilar.
- Biosimilar sameAs بیوژنریک.
- Biosimilar sameAs Biosimilaari_lääke.
- Biosimilar sameAs Médicament_biosimilaire.
- Biosimilar sameAs Biohasonló_gyógyszer.
- Biosimilar sameAs Farmaco_biosimilare.
- Biosimilar sameAs 바이오시밀러.
- Biosimilar sameAs Biosimilar.
- Biosimilar sameAs m.02y__63.
- Biosimilar sameAs Podobno_biološko_zdravilo.
- Biosimilar sameAs Biosimilar.
- Biosimilar sameAs Q864715.
- Biosimilar wasDerivedFrom Biosimilar?oldid=704467158.
- Biosimilar isPrimaryTopicOf Biosimilar.