Switching between different ESAs

Posted 27/05/2016

Switching between reference biologicals and biosimilars can be a contentious issue. A study from Italy, however, has found that this phenomenon is not limite...

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Cost-effectiveness analysis and incentivizing i... Generics/Research | Posted 27/05/2016
Industry calls for generics user fees to be red... Policies & Legislation | Posted 27/05/2016
Positive phase III results for omalizumab copy... Biosimilars/News | Posted 27/05/2016
GSK appeals UK pay-for-delay fine Generics/News | Posted 27/05/2016
Uptake of biosimilars increasing in Spain Biosimilars/Research | Posted 20/05/2016
Clinical and regulatory issues for biosimilars Biosimilars/Research | Posted 20/05/2016
Samsung Bioepis to launch infliximab biosimilar... Biosimilars/News | Posted 20/05/2016
Perceptions of the value of generics in Brazil Generics/Research | Posted 20/05/2016
Japan proving to be a favourable market for bio... Biosimilars/General | Posted 20/05/2016
Australian generics maker opens clinical trials... Generics/General | Posted 20/05/2016
Approaches to increase uptake of biosimilars in... Biosimilars/Research | Posted 13/05/2016
Benepali wins Danish tender for etanercept Biosimilars/General | Posted 13/05/2016
Perceptions of the substitution of generics Generics/Research | Posted 13/05/2016
Generics applications under review by EMA – Apr... Generics/General | Posted 13/05/2016
FDA approves first generic rosuvastatin Generics/News | Posted 13/05/2016
A strategic approach to increase uptake of bios... Biosimilars/Research | Posted 06/05/2016
Biosimilars applications under review by EMA –... Biosimilars/General | Posted 06/05/2016
Perceptions of the safety and side effects of g... Generics/Research | Posted 06/05/2016
China introduces new quality and efficacy requi... Policies & Legislation | Posted 06/05/2016
FDA issues guidance on data integrity and GMP Guidelines | Posted 06/05/2016
FDA approves highest number of generics in 2015 Generics/General | Posted 06/05/2016
Improving uptake of biosimilars in Spain Biosimilars/Research | Posted 29/04/2016
Perceptions of the effectiveness and quality of... Generics/Research | Posted 29/04/2016
Samsung Bioepis starts phase III trial for beva... Biosimilars/News | Posted 29/04/2016
Colombia recommends compulsory licence for Glivec Policies & Legislation | Posted 29/04/2016
Biosimilars group launched in UK to improve bio... Biosimilars/General | Posted 29/04/2016
India’s bulk drug exports on the increase Generics/General | Posted 29/04/2016
US rheumatologists in favour of distinct names... Biosimilars/General | Posted 22/04/2016
Payers in US getting ready for biosimilars Reports | Posted 22/04/2016
Generics perceptions in patients, pharmacists a... Generics/Research | Posted 22/04/2016
Biosimilars: the clinical perspective Biosimilars/Research | Posted 22/04/2016
New administration route for epoetin alfa biosi... Biosimilars/News | Posted 22/04/2016
Australia announces price cuts for common presc... Policies & Legislation | Posted 22/04/2016
Sun Pharma to buy 14 drug brands from Novartis... Generics/News | Posted 22/04/2016
A multidisciplinary perspective on biosimilars Biosimilars/Research | Posted 15/04/2016
Substitution of generic antiepileptic drugs Generics/Research | Posted 15/04/2016
Biosimilars: management of clinical issues Biosimilars/Research | Posted 15/04/2016
BioOutsource launches ready-to-use biosimilarit... Biosimilars/News | Posted 15/04/2016
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NON-BIOLOGICAL COMPLEX DRUGS

Is a new pathway for NBCDs on the way in the US? Posted 27/05/2016

The US Food and Drug Administration (FDA) does not formerly recognize non-bio...

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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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