Clinical data requirements for biosimilars in the EU

Posted 11/10/2019

In their article [1], authors from the Paul-Ehrlich-Institut, the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (Bf...

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FDA releases new patient guidance on biosimilars Biosimilars/General | Posted 11/10/2019
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Biosimilars applications reviewed in the EU Biosimilars/Research | Posted 04/10/2019
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Novo Nordisk to launch biosimilar insulin in th... Biosimilars/General | Posted 04/10/2019
iBio and CC-Pharming collaborate for rituximab... Biosimilars/News | Posted 04/10/2019
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New evidence: comparable clinical outcomes for... Generics/Research | Posted 04/10/2019
Carcinogen contamination halts distribution of... Generics/General | Posted 04/10/2019
Positive EMA-CHMP opinion for SC infliximab bio... Biosimilars/News | Posted 27/09/2019
Mylan’s insulin biosimilar blocked, but wins pa... Biosimilars/General | Posted 27/09/2019
Samsung Bioepis to supply Brenzys to Brazil und... Biosimilars/News | Posted 27/09/2019
Switching from originator infliximab to CT-P13:... Biosimilars/Research | Posted 27/09/2019
Evaluating success: generics substitution polic... Generics/Research | Posted 27/09/2019
EMA approves leukaemia and multiple myeloma gen... Generics/News | Posted 27/09/2019
A call to end US drug pricing games Policies & Legislation | Posted 27/09/2019
Trastuzumab biosimilar Herzuma approved in Canada Biosimilars/News | Posted 20/09/2019
UnitedHealthcare to preferentially cover Amgen’... Biosimilars/General | Posted 20/09/2019
China approves new formulation of etanercept co... Biosimilars/News | Posted 20/09/2019
FDA’s global inspection strategy strengthened Generics/General | Posted 20/09/2019
Generics in Chile: policy success but promotion... Generics/Research | Posted 20/09/2019
Screening protein surface biosimilarity of ritu... Biosimilars/Research | Posted 20/09/2019
China eases generic medicine import laws Policies & Legislation | Posted 20/09/2019
Canadian IBD charity updates biosimilar positio... Biosimilars/General | Posted 13/09/2019
Herzuma gains Japanese approval for three-week... Biosimilars/News | Posted 13/09/2019
TRIPS flexibilities: current and future use in... Generics/Research | Posted 13/09/2019
More positive phase III results for rituximab b... Biosimilars/Research | Posted 13/09/2019
FDA organizes workshop on complex generics Guidelines | Posted 13/09/2019
Clinical comparability between rituximab biosim... Biosimilars/Research | Posted 13/09/2019
Revance Therapeutics focus on its own Botox bio... Biosimilars/News | Posted 13/09/2019
Challenges for European pharmacovigilance Reports | Posted 06/09/2019
Teriparatide biosimilar Terrosa launched in Europe Biosimilars/News | Posted 06/09/2019
Improving access to medicines: the Doha Declara... Generics/Research | Posted 06/09/2019
Praise for Canada’s BC after it adopts biosimil... Policies & Legislation | Posted 06/09/2019
Switching from reference to biosimilar inflixim... Biosimilars/Research | Posted 06/09/2019
Court rules Amgen’s patents on Enbrel are valid... Biosimilars/General | Posted 06/09/2019
Positive results for Bio-Thera’s arthritis copy... Biosimilars/Research | Posted 06/09/2019
Mylan launches adalimumab biosimilar Hulio in S... Biosimilars/News | Posted 06/09/2019
Perceptions of biosimilars among US cancer pati... Biosimilars/Research | Posted 30/08/2019
Heparin biosimilar to be marketed in Canada Biosimilars/News | Posted 30/08/2019


FDA issues final guidance on liposome drug products Posted 27/04/2018

On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft...


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Impax announces FDA approval of follow-on sevel... Non‐Biological Complex Drugs/News | Posted 17/11/2017
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Scientific and regulatory considerations for fo... Non‐Biological Complex Drugs/Research | Posted 05/05/2017
Equivalence of complex drug products Non‐Biological Complex Drugs/Reports | Posted 14/04/2017
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Warning letter causes delays for follow-on glat... Non‐Biological Complex Drugs/News | Posted 17/03/2017
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In vitro analysis of follow-on versions of seve... Non‐Biological Complex Drugs/Research | Posted 18/11/2016
Determining the bioequivalence of follow-on iro... Non‐Biological Complex Drugs/Reports | Posted 04/11/2016
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Rigorous approach used to approve a follow-on v... Non‐Biological Complex Drugs/Research | Posted 29/07/2016
US guidelines for follow-on NBCDs Non‐Biological Complex Drugs/Guidelines | Posted 10/06/2016
Non-biological complex drugs and their follow-o... Non‐Biological Complex Drugs/Research | Posted 03/06/2016
Is a new pathway for NBCDs on the way in the US? Non‐Biological Complex Drugs/Polices & Legislation | Posted 27/05/2016
Follow-on glatiramer acetate gains European app... Non‐Biological Complex Drugs/News | Posted 13/05/2016
FDA includes follow-on versions in its new cycl... Non‐Biological Complex Drugs/Guidelines | Posted 29/04/2016
Switching between originator and follow-on iron... Non‐Biological Complex Drugs/Research | Posted 22/04/2016
Follow-on intravenous iron formulations in haem... Non‐Biological Complex Drugs/Research | Posted 01/04/2016
Glatiramoid follow-on NBCDs Non‐Biological Complex Drugs/Reports | Posted 11/03/2016
FDA includes follow-on versions in its new lipo... Non‐Biological Complex Drugs/Guidelines | Posted 26/02/2016
EU guidelines for follow-on NBCDs Non‐Biological Complex Drugs/Guidelines | Posted 22/01/2016
GDUFA regulatory priorities for 2016 include co... Non‐Biological Complex Drugs/Polices & Legislation | Posted 11/12/2015
Liposomal follow-on NBCDs Non‐Biological Complex Drugs/Reports | Posted 11/12/2015
Regulations for follow-on NBCDs Non‐Biological Complex Drugs/Reports | Posted 13/11/2015
Status and regulatory issues surrounding follow... Non‐Biological Complex Drugs/Reports | Posted 05/11/2015
Follow-on glatiramer acetate (M356) claimed as... Non‐Biological Complex Drugs/Research | Posted 05/11/2015
EMA issues reflection paper for follow-on versi... Non‐Biological Complex Drugs/Guidelines | Posted 05/11/2015
FDA approves first follow-on version of glatira... Non‐Biological Complex Drugs/News | Posted 05/11/2015