EMA opens consultation on revision of biosimilar G-CSF guideline

posted 31/07/2015

On 27 July 2015, the European Medicines Agency (EMA) released a draft concept paper to discuss its planned revision of its specific guideline for biosimilars...

Approval of biosimilar insulins: regulations ac... Biosimilars/Research | Posted 31/07/2015
Biosimilar infliximab offered to French hospita... Biosimilars/News | Posted 31/07/2015
Effect of price caps and reference pricing on g... Generics/Research | Posted 31/07/2015
ACR position statement on biosimilars addresses... Biosimilars/General | Posted 31/07/2015
Efficacy of filgrastim biosimilars following st... Biosimilars/Research | Posted 31/07/2015
Actavis hit with lawsuit over generic version o... Generics/News | Posted 31/07/2015
Norway, biosimilars in different funding systems Biosimilars/Research | Posted 03/07/2015
Effect of co-insurance and reference pricing on... Generics/Research | Posted 03/07/2015
Biosimilars substitution bill become law in Texas Policies & Legislation | Posted 03/07/2015
Generics prices in US decrease again in 2013 Reports | Posted 03/07/2015
Biosimilars licensing agreements for AMP and Fo... Biosimilars/News | Posted 03/07/2015
Indian pharma industry to get government support Generics/General | Posted 03/07/2015
Polish firm gets EIB loan for biosimilars devel... Biosimilars/General | Posted 03/07/2015
Mylan launches generic asthma inhaler in UK Generics/News | Posted 03/07/2015
Concerns raised over Australian decision to sub... Biosimilars/General | Posted 26/06/2015
Approval of biosimilars in rheumatology Biosimilars/Research | Posted 26/06/2015
Real-life results for Inflectra compared to Rem... Biosimilars/Research | Posted 26/06/2015
Effect of reference pricing on generics entry Generics/Research | Posted 26/06/2015
Ranibizumab similar biologic launched in India Biosimilars/News | Posted 26/06/2015
Generics of ADHD drug launched in US Generics/News | Posted 26/06/2015
Acquisitions for Endo and Strides Pharma News | Posted 26/06/2015
Biosimilars in the US Biosimilars/Research | Posted 19/06/2015
Australia’s PBAC recommends substitution of bio... Biosimilars/General | Posted 19/06/2015
Biosimilars substitution bills become law in fo... Policies & Legislation | Posted 19/06/2015
Biosimilar events from 2013 to 2015 Reports | Posted 19/06/2015
FDA approves first once-daily glatirimer acetat... Biosimilars/News | Posted 19/06/2015
Remsima shows comparable safety and efficacy in... Biosimilars/Research | Posted 19/06/2015
BioProduction 2015 Conferences | Posted 19/06/2015
Malaysian physicians have negative perceptions... Generics/Research | Posted 12/06/2015
Biosimilars for the treatment of Crohn’s disease Biosimilars/Research | Posted 12/06/2015
EMA to hold webinar on publication of clinical... Policies & Legislation | Posted 12/06/2015
Inflectra shows comparable results in IBD patients Biosimilars/Research | Posted 12/06/2015
Spanish Society of Rheumatology issues position... Biosimilars/General | Posted 12/06/2015
Osteoporosis and ADHD generics launched in USA Generics/News | Posted 12/06/2015
World Biosimilar Congress Europe 2015 Conferences | Posted 12/06/2015
Cost of filgrastim biosimilars compared to orig... Biosimilars/Research | Posted 05/06/2015
Drug evergreening strategies in India Generics/Research | Posted 05/06/2015
Biosimilars applications under review by EMA –... Biosimilars/General | Posted 05/06/2015
Generics applications under review by EMA – Apr... Generics/General | Posted 05/06/2015
Indian drugmakers make progress with candidate... Biosimilars/News | Posted 05/06/2015
FDA receives application for first generic of H... Generics/News | Posted 05/06/2015

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