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- Q864715 subject Q22695562.
- Q864715 subject Q7214254.
- Q864715 subject Q7237918.
- Q864715 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.".
- Q864715 wikiPageExternalLink thomas.loc.gov.
- Q864715 wikiPageExternalLink whats-keeping-generic-version-biologic-drugs-u-s-market.
- Q864715 wikiPageWikiLink Q130146.
- Q864715 wikiPageWikiLink Q134549.
- Q864715 wikiPageWikiLink Q1414593.
- Q864715 wikiPageWikiLink Q14852026.
- Q864715 wikiPageWikiLink Q15268054.
- Q864715 wikiPageWikiLink Q1550789.
- Q864715 wikiPageWikiLink Q188269.
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- Q864715 wikiPageWikiLink Q1988322.
- Q864715 wikiPageWikiLink Q204711.
- Q864715 wikiPageWikiLink Q21163221.
- Q864715 wikiPageWikiLink Q213901.
- Q864715 wikiPageWikiLink Q22695562.
- Q864715 wikiPageWikiLink Q2359937.
- Q864715 wikiPageWikiLink Q285697.
- Q864715 wikiPageWikiLink Q30.
- Q864715 wikiPageWikiLink Q3151081.
- Q864715 wikiPageWikiLink Q415264.
- Q864715 wikiPageWikiLink Q422248.
- Q864715 wikiPageWikiLink Q507154.
- Q864715 wikiPageWikiLink Q5690616.
- Q864715 wikiPageWikiLink Q679692.
- Q864715 wikiPageWikiLink Q7144493.
- Q864715 wikiPageWikiLink Q7214254.
- Q864715 wikiPageWikiLink Q7237918.
- Q864715 wikiPageWikiLink Q7705761.
- Q864715 wikiPageWikiLink Q8054.
- Q864715 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.".
- Q864715 label "Biosimilar".