1325 results
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Data exclusivity / Generics / Biosimilars: Regulatory and procedural guidance
Last updated: 31/12/2009Data exclusivity / Generics / Biosimilars: Regulatory and procedural … Data exclusivity / Generics / Biosimilars: Regulatory and procedural …
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Multidisciplinary: biosimilar
Last updated: 29/06/2016Multidisciplinary: biosimilar … Multidisciplinary: biosimilar …
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Biosimilar medicines: Overview
Last updated: 26/04/2023Biosimilar medicines: Overview … Biosimilar medicines: Overview … supporting interchangeability of biosimilar medicines in the EU The …
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Biosimilar medicines: marketing authorisation
Last updated: 19/08/2019Biosimilar medicines: marketing authoris … Biosimilar medicines: marketing authoris …
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Workshop on biosimilars
European Medicines Agency, London, UK, 31/10/2013, Last updated: 12/11/2013Workshop on biosimilars … Workshop on biosimilars … Agenda - Workshop on biosimilars 2013 7 Westferry Circus … -
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Biosimilar Medicinal Products Working Party
Last updated: 31/12/2009Biosimilar Medicinal Products Working … Biosimilar Medicinal Products Working … Biosimilar A substance or combination …
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News: Facilitating global development of biosimilars
Last updated: 29/10/2014tating global development of biosimilars … application/pdf guideline on biosimilars . The main change brought … clinical investigation of a biosimilar. This new concept is expected … -
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News: Biosimilar medicines can be interchanged
CHMP, Last updated: 19/09/2022Biosimilar medicines can be interchanged … information can be found under 'Biosimilar medicines - Overview'. biosimilar medicines approved in the … medicine or with an equivalent biosimilar. While interchangeable use of … -
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News: Improving understanding of biosimilars in the EU
Last updated: 13/09/2018Improving understanding of biosimilars in the EU … information can be found under 'Biosimilar medicines - Overview'. biosimilar medicines , as part of their … improve understanding of biosimilars across the European Union … -
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News: European Medicines Agency organising workshop on biosimilars
CHMP, Last updated: 25/09/2013Agency organising workshop on biosimilars … is holding a workshop on biosimilars on 31 October 2013. The Agency … guidelines. guidelines on biosimilars. These are: the … -
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News: Workshop on biosimilars takes place today
Last updated: 31/10/2013Workshop on biosimilars takes place today … Agency's (EMA) workshop on biosimilars is taking place at the Agency … overarching guidelines on biosimilars. The aim of this workshop … -
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Press release: New guide on biosimilar medicines for healthcare professionals
Last updated: 05/05/2017New guide on biosimilar medicines for healthcare … Increasing understanding of biosimilar medicines … New guide on biosimilar medicines for healthcare … -
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News: Comments invited on draft revised guideline on biosimilars
Last updated: 08/05/2013draft revised guideline on biosimilars … draft revised guideline on biosimilars … 6 7 Draft agreed by Biosimilar Medicinal Products Working … -
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News: Revised guideline on quality of biosimilar medicines open for comments
CHMP, Last updated: 31/05/2012ised guideline on quality of biosimilar medicines open for comments … ised guideline on quality of biosimilar medicines open for comments … biological medicinal product, biosimilar, recombinant proteins, quality … -
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Workshop on biosimilar monoclonal antibodies and immunogenicity of monoclonal antibodies
European Medicines Agency, London, UK, 24/10/2011, Last updated: 15/06/2012Workshop on biosimilar monoclonal antibodies and … Medicines Agency workshop on biosimilar monoclonal antibodies is … Documents Agenda - Workshop on biosimilar monoclonal antibodies and … -
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Gulf Cooperation Council (GCC) Biosimilar Medicinal Products Workshop
Riyadh, Saudi Arabia, from 19/04/2011 to 20/04/2011, Last updated: 23/06/2011Cooperation Council (GCC) Biosimilar Medicinal Products Workshop … parties. Documents Agenda - GCC Biosimilar Medicinal Products Workshop … Generic Presentation - EU Biosimilar Regulatory Framework II … -
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Joint EMA / European Directorate for the Quality of Medicines and Healthcare (EDQM) event on biosimilars
EDQM, 7 allée Kastner, 67081 Strasbourg, France, 08/02/2017, Last updated: 26/01/2017Healthcare (EDQM) event on biosimilars … framework in the field of biosimilar products. A European Union … on quality assessment of biosimilars. Related content Programme … -
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News: Tailored scientific advice to support step-by-step development of new biosimilars
Last updated: 16/12/2016step-by-step development of new biosimilars … for the development path of biosimilar medicines. Through this new … to provide developers of biosimilars with advice on the studies/tests … -
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Press release: European Medicines Agency recommends approval of first two monoclonal-antibody biosimilars
CHMP, Last updated: 28/06/2013first two monoclonal-antibody biosimilars … mendation marks extension of biosimilar concept to new product class … Press release_first biosimilar MAB 7 Westferry Circus … -
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News: Revised guideline on biosimilars containing biotechnology-derived proteins published for public consultation
CHMP, Last updated: 10/06/2013Revised guideline on biosimilars containing biotechnology-derived … Revised guideline on biosimilars containing biotechnology-derived … 7 8 Draft agreed by Biosimilar Medicinal Products Working … -
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News: European Medicines Agency to accept biosimilar reference medicines sourced outside European Economic Area
Last updated: 28/09/2012Medicines Agency to accept biosimilar reference medicines sourced … pharmaceutical companies on biosimilar medicines to reflect the … the global development of biosimilars and avoid the unnecessary … -
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News: Public consultation opens on draft guideline on biosimilars containing low-molecular-weight heparins
CHMP, Last updated: 31/01/2013opens on draft guideline on biosimilars containing low-molecular-weight … opens on draft guideline on biosimilars containing low-molecular-weight … low-7 molecular-weight-heparins8 Draft9 10 Draft agreed by Biosimilar Medicinal Products Working … -
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News: European Medicines Agency releases guideline on biosimilar interferon beta for public consultation
CHMP, Last updated: 20/01/2012Agency releases guideline on biosimilar interferon beta for public … Agency releases guideline on biosimilar interferon beta for public … biological medicinal product, biosimilar, comparability, non-clinical … -
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Generic and biosimilar medicines in the centralised procedure: 3rd EMA-EGA information day
London, 10/11/2010, Last updated: 09/11/2010Generic and biosimilar medicines in the centralised … Association (EGA) on generic and biosimilar medicines in the centralised … EMA-EGA Info Day - Generic and biosimilar medicines in the centralised … -
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News: Draft guideline on biosimilar medicines containing monoclonal antibodies released for consultation
Last updated: 26/11/2010Draft guideline on biosimilar medicines containing monoclonal … Draft guideline on biosimilar medicines containing monoclonal … BMWP.Secretariat@ema.europa.eu 9 Keywords Biosimilars, monoclonal antibodies, similar …