Pharmacovigilance of biologicals in Denmark

Posted 19/08/2016

As a result of the increasing use of biologicals and biosimilars in Denmark, the Ministry of Health (MoH) in partnership with the country’s regulatory agency...

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Biosimilars of omalizumab Biosimilars/General | Posted 19/08/2016
Mylan and Biocon submit pegfilgrastim biosimila... Biosimilars/News | Posted 19/08/2016
EMA halts sales of unreliable generics Generics/General | Posted 19/08/2016
Bevacizumab similar biologics launched in India Biosimilars/News | Posted 19/08/2016
Evolution of biosimilars in developed and devel... Biosimilars/Research | Posted 19/08/2016
Launches, approvals and court cases for Sun Pharma Generics/News | Posted 19/08/2016
Biosimilars: the benefits need to be communicated Biosimilars/Research | Posted 12/08/2016
Samsung Bioepis adalimumab biosimilar submitted... Biosimilars/News | Posted 12/08/2016
Teva to acquire US-based generics maker Anda Pharma News | Posted 12/08/2016
Sandoz plans to launch five more biosimilars by... Biosimilars/General | Posted 12/08/2016
FDA approves first generic nilutamide for treat... Generics/News | Posted 12/08/2016
World Biosimilar Congress USA 2017 Conferences | Posted 12/08/2016
Biosimilars: clinicians and regulators need to... Biosimilars/Research | Posted 05/08/2016
FDA rejects Sandoz’s biosimilar pegfilgrastim a... Biosimilars/News | Posted 05/08/2016
The satisfaction of healthcare payers, patients... Generics/Research | Posted 05/08/2016
Pure red cell aplasia in a CKD patient after tr... Biosimilars/Research | Posted 05/08/2016
New proposed bipartisan legislation would cut b... Policies & Legislation | Posted 05/08/2016
Extortionate increases in prices of 32 drugs a... Generics/General | Posted 05/08/2016
FDA advisors recommend approval of Sandoz’s eta... Biosimilars/News | Posted 29/07/2016
Ways to reduce drug costs in Australia Generics/Research | Posted 29/07/2016
FDA withdraws biosimilar suffix proposal Guidelines | Posted 29/07/2016
Biosimilars of tocilizumab Biosimilars/General | Posted 29/07/2016
The economic impact of biosimilars in the US Biosimilars/Research | Posted 29/07/2016
Positive clinical data for three anti-TNF-α bio... Biosimilars/Research | Posted 29/07/2016
Teva generics being snapped up by rivals Pharma News | Posted 29/07/2016
AES position statement on substitution of gener... Generics/Research | Posted 01/07/2016
Doctors want more details in biosimilars labelling Biosimilars/Research | Posted 01/07/2016
Healthcare alliance proposes ways to reduce dru... Generics/General | Posted 01/07/2016
Mylan presents comparability data for trastuzum... Biosimilars/Research | Posted 01/07/2016
New bill would stop brand-name pharma restricti... Policies & Legislation | Posted 01/07/2016
Real-world safety data for epoetin alfa biosimilar Biosimilars/Research | Posted 01/07/2016
Global generics market expected to grow Reports | Posted 01/07/2016
Biosimilars Europe 2016 Conferences | Posted 01/07/2016
Health Canada approves Inflectra biosimilar for... Biosimilars/News | Posted 24/06/2016
Reasons for the success of a generics company i... Generics/Research | Posted 24/06/2016
Biosimilar rituximab in biological naïve rheuma... Biosimilars/Research | Posted 24/06/2016
Insulin biosimilar meets primary endpoint in ph... Biosimilars/Research | Posted 24/06/2016
Glenmark gains approval for anti-epileptic generic Generics/News | Posted 24/06/2016
AMRI acquires API maker Euticals Pharma News | Posted 24/06/2016
World Biosimilar Congress Europe 2016 Conferences | Posted 24/06/2016
Improvement in uptake of biosimilars in Spain Biosimilars/Research | Posted 17/06/2016
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NON-BIOLOGICAL COMPLEX DRUGS

Iron carbohydrate follow-on NBCDs Posted 12/08/2016

Follow-on versions of iron–carbohydrate non-biological complex drugs (NBCDs)...

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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
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Generics News Research General

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Biosimilars News Research General

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