"Klinick\u00E1 onkologie" . "Pojem biosimilars je pou\u017E\u00EDv\u00E1n pro l\u00E9\u010Div\u00E9 l\u00E1tky, kter\u00E9 jsou vyv\u00EDjeny a uv\u00E1d\u011Bny na trh po vypr\u0161en\u00ED patentov\u00E9 ochrany origin\u00E1ln\u00EDch biotechnologicky vyr\u00E1b\u011Bn\u00FDch l\u00E9\u010Div. V z\u00E1mo\u0159\u00ED se pro stejnou skupinu pou\u017E\u00EDv\u00E1 term\u00EDn Follow-on-Biologics (FOBs). Biotechnologick\u00E1 l\u00E9\u010Diva maj\u00ED ve srovn\u00E1n\u00ED s chemicky definovan\u00FDmi l\u00E9\u010Divy mnoho odli\u0161nost\u00ED, kter\u00E9 znesnad\u0148uj\u00ED nebo tak\u0159ka znemo\u017E\u0148uj\u00ED jejich, by\u0165 leg\u00E1ln\u00ED, \u201Ekop\u00EDrov\u00E1n\u00ED\u201C. Biosimilars tedy nejsou a z podstaty ani nemohou b\u00FDt prost\u00FDmi kopiemi origin\u00E1ln\u00EDch biotechnologick\u00FDch l\u00E9\u010Div a regula\u010Dn\u00ED \u00FA\u0159ady k nim ani takto nep\u0159istupuj\u00ED. Z\u00E1v\u011Brem je mo\u017En\u00E9 konstatovat, \u017Ee v r\u00E1mci evropsk\u00E9 legislativy jsou nastavena jasn\u00E1 pravidla, kter\u00E1 mus\u00ED b\u00FDt pro registraci biosimilars dodr\u017Eena a jejich\u017E c\u00EDlem je registrovat a uv\u00E9st na trh pouze takov\u00E9 p\u0159\u00EDpravky, je\u017E jsou prokazateln\u011B kvalitn\u00ED, \u00FA\u010Dinn\u00E9 a pro pacienty bezpe\u010Dn\u00E9." . "RIV/00209805:_____/14:#0000512" . "Pojem biosimilars je pou\u017E\u00EDv\u00E1n pro l\u00E9\u010Div\u00E9 l\u00E1tky, kter\u00E9 jsou vyv\u00EDjeny a uv\u00E1d\u011Bny na trh po vypr\u0161en\u00ED patentov\u00E9 ochrany origin\u00E1ln\u00EDch biotechnologicky vyr\u00E1b\u011Bn\u00FDch l\u00E9\u010Div. V z\u00E1mo\u0159\u00ED se pro stejnou skupinu pou\u017E\u00EDv\u00E1 term\u00EDn Follow-on-Biologics (FOBs). Biotechnologick\u00E1 l\u00E9\u010Diva maj\u00ED ve srovn\u00E1n\u00ED s chemicky definovan\u00FDmi l\u00E9\u010Divy mnoho odli\u0161nost\u00ED, kter\u00E9 znesnad\u0148uj\u00ED nebo tak\u0159ka znemo\u017E\u0148uj\u00ED jejich, by\u0165 leg\u00E1ln\u00ED, \u201Ekop\u00EDrov\u00E1n\u00ED\u201C. Biosimilars tedy nejsou a z podstaty ani nemohou b\u00FDt prost\u00FDmi kopiemi origin\u00E1ln\u00EDch biotechnologick\u00FDch l\u00E9\u010Div a regula\u010Dn\u00ED \u00FA\u0159ady k nim ani takto nep\u0159istupuj\u00ED. Z\u00E1v\u011Brem je mo\u017En\u00E9 konstatovat, \u017Ee v r\u00E1mci evropsk\u00E9 legislativy jsou nastavena jasn\u00E1 pravidla, kter\u00E1 mus\u00ED b\u00FDt pro registraci biosimilars dodr\u017Eena a jejich\u017E c\u00EDlem je registrovat a uv\u00E9st na trh pouze takov\u00E9 p\u0159\u00EDpravky, je\u017E jsou prokazateln\u011B kvalitn\u00ED, \u00FA\u010Dinn\u00E9 a pro pacienty bezpe\u010Dn\u00E9."@cs . "3"^^ . . . "Demlov\u00E1, Regina" . "Biosimilars (ne)jen v onkologii \u2013 dne\u0161n\u00ED realita i budoucnost" . . "Biosimilars in oncology \u2013 present and future"@en . . . "RIV/00209805:_____/14:#0000512!RIV15-MSM-00209805" . "CZ - \u010Cesk\u00E1 republika" . . . "Biosimilars (ne)jen v onkologii \u2013 dne\u0161n\u00ED realita i budoucnost"@cs . "P(ED2.1.00/03.0101)" . "Biosimilars are drugs, that are developed and lanuched after the patent rights of original biotechnological drugs are expired, beyond the sea, they are called Follow-on-Biologics (FOBs). Biotechnological drugs differ from chemically defined drugs and cannot be copied legally. Therefore, biosimilars are not simple copies of original biotechnological drugs and strict ruels must be abiden for their registration in order to secure the drug quality, effectiveness and patient\u02BCs safety."@en . "1" . . "biosimilars; monoclonal antibody; drug"@en . . "5487" . . . "1"^^ . "27" . "Biosimilars (ne)jen v onkologii \u2013 dne\u0161n\u00ED realita i budoucnost" . "Biosimilars in oncology \u2013 present and future"@en . . "1"^^ . . . "0862-495X" . "[BC18C69B14F9]" . "http://www.linkos.cz/files/klinicka-onkologie/183/4399.pdf" . "Biosimilars (ne)jen v onkologii \u2013 dne\u0161n\u00ED realita i budoucnost"@cs . .