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Revision of guideline on clinical and non-clinical issues for biosimilars

 posted 14/06/2013

On 10 June 2013, EMA released a revision of the guideline addressing the clinical and non-clinical issues related to similar biological products (biosimilars...

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Use of G-CSF biosimilars for reduction of fever Biosimilars/Research | Posted 14/06/2013
Possibility of substitution of biosimilars in E... Reports | Posted 14/06/2013
Teva and Sun Pharma settle battle over generic... Generics/News | Posted 14/06/2013
Trials to start for biosimilar infliximab and e... Biosimilars/News | Posted 14/06/2013
Nigeria needs to combat fake drugs and ageing f... Pharma News | Posted 14/06/2013
Indian Government moves closer to complying wit... Policies & Legislation | Posted 14/06/2013
EMA’s Richardson talks about biosimilars in Europe Reports | Posted 07/06/2013
Positive post-marketing data for biosimilar epo... Biosimilars/Research | Posted 07/06/2013
EU to fine 9 drugmakers over pay-for-delay deals Policies & Legislation | Posted 07/06/2013
Celltrion applies for Korean approval of biosim... Biosimilars/News | Posted 07/06/2013
Use of G-CSF biosimilars for stem cell mobiliza... Biosimilars/Research | Posted 07/06/2013
Sun Pharma looking to buy Sweden’s Meda Pharma News | Posted 07/06/2013
Biologicals sales have almost doubled since 2006 Biosimilars/General | Posted 07/06/2013
Dr Reddy’s and Fujifilm call off joint venture... Generics/News | Posted 07/06/2013
Equivalence of generic immunosuppressants Generics/Research | Posted 31/05/2013
Biopharmaceutical products in Iran Biosimilars/Research | Posted 31/05/2013
Amgen, Hospira and Sandoz set to dominate US bi... Reports | Posted 31/05/2013
Ireland passes bill to encourage generics use Policies & Legislation | Posted 31/05/2013
Russia to harmonize biologicals regulations Biosimilars/News | Posted 31/05/2013
US appeals court halts Pulmicort generics Generics/News | Posted 31/05/2013
Lipitor generics saved UK NHS £350 million in f... Generics/General | Posted 31/05/2013
India introduces new drug pricing control Policies & Legislation | Posted 31/05/2013
Biosimilars and US exclusivity Biosimilars/General | Posted 24/05/2013
Sandoz to start phase III etanercept trial Biosimilars/Research | Posted 24/05/2013
Kazakhstan, Russia, Ukraine to change drug reim... Policies & Legislation | Posted 24/05/2013
Use of G-CSF biosimilars for stem cell mobiliza... Biosimilars/Research | Posted 24/05/2013
Actavis makes definitive agreement with Warner... Pharma News | Posted 24/05/2013
Peruvian guidelines for ‘biosimilar biologic’ p... Guidelines | Posted 24/05/2013
Ranbaxy pays US$500 million to resolve US litig... Generics/News | Posted 24/05/2013
Huahai and Oncobiologics make biosimilars deal Biosimilars/News | Posted 24/05/2013
Sanofi fined for discouraging generic clopidogr... Generics/News | Posted 17/05/2013
Australia reviews chemotherapy drug subsidies Policies & Legislation | Posted 17/05/2013
US places India on IP black list Reports | Posted 17/05/2013
Actavis in discussions to buy Warner Chilcott Pharma News | Posted 17/05/2013
FDA rejects Endo petition to stop Opana ER gene... Generics/News | Posted 17/05/2013
Updated guideline on the use of epoetin and dar... Guidelines | Posted 17/05/2013
The biggest drug patent losses for 2013 Generics/General | Posted 17/05/2013
Agila Biotech and Pfenex make biosimilars deal Biosimilars/News | Posted 17/05/2013
Innovation in the generics industry Generics/Research | Posted 10/05/2013
Use of biosimilars in Europe Reports | Posted 10/05/2013
EMA issues draft revision of overarching biosim... Guidelines | Posted 10/05/2013
Philippines urged to import drugs from Bangladesh Pharma News | Posted 10/05/2013
Sanofi starts biosimilar insulin trials Biosimilars/News | Posted 10/05/2013
Valeant deal to acquire Actavis on hold Pharma News | Posted 10/05/2013
Intas launches rituximab ‘similar biologic’ in... Biosimilars/News | Posted 10/05/2013
Generics makers to self-identify for FY2014 gen... Policies & Legislation | Posted 10/05/2013
EMA publishes concept paper on extrapolation Policies & Legislation | Posted 03/05/2013
Development of biosimilars for rheumatology Biosimilars/Research | Posted 03/05/2013
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