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Biosimilars applications under review by EMA – July 2020

 Posted 10/07/2020

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosi...

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Canada approves infliximab and filgrastim biosi... Biosimilars/News | Posted 10/07/2020
COVID-19 drug trials underway Pharma News | Posted 10/07/2020
Denmark achieves 83% reduction in adalimumab co... Biosimilars/Research | Posted 10/07/2020
The cost of biologicals in Canada Reports | Posted 10/07/2020
Revance and Mylan move forward with Botox biosi... Biosimilars/News | Posted 10/07/2020
EMA and FDA agree new priorities, including res... Policies & Legislation | Posted 10/07/2020
Cost-effectiveness of generic dabigatran Generics/Research | Posted 10/07/2020
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Japanese approval for first adalimumab biosimilar Biosimilars/News | Posted 03/07/2020
US biosimilars pipeline for growth hormone and... Reports | Posted 03/07/2020
Biosimilars in Belgium: increasing competition Biosimilars/Research | Posted 03/07/2020
Positive phase I results for Innovent’s ipilimu... Biosimilars/Research | Posted 03/07/2020
EC approval for etanercept biosimilar Nepexto Biosimilars/News | Posted 03/07/2020
Judge rules in AbbVie’s favour over biosimilar... Policies & Legislation | Posted 03/07/2020
Analysis of biological sales for OECD countries Reports | Posted 03/07/2020
Generics of apixaban and chlorzoxazone approved... Generics/News | Posted 03/07/2020
US biosimilars pipeline for supportive care, on... Reports | Posted 26/06/2020
China approves bevacizumab copy biological Byvasda Biosimilars/News | Posted 26/06/2020
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Trends in biological drugs in Canada Reports | Posted 26/06/2020
Successfully transitioning patients with IBD to... Biosimilars/Research | Posted 26/06/2020
Canada approves pegfilgrastim biosimilar Ziextenzo Biosimilars/News | Posted 26/06/2020
Differences in originator and generic drug labe... Generics/Research | Posted 26/06/2020
EULAR recommendations for DMARDs in rheumatoid... Biosimilars/Research | Posted 26/06/2020
Medscape hosts virtual symposium on biosimilars... Biosimilars/General | Posted 26/06/2020
Approval and launch dates for US biosimilars Reports | Posted 19/06/2020
FDA approves insulin glargine biosimilar Semglee Biosimilars/News | Posted 19/06/2020
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Positive phase Ib results for TYVYT + bevacizum... Biosimilars/Research | Posted 19/06/2020
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Daewon launches teriparatide biosimilar in Sout... Biosimilars/News | Posted 19/06/2020
Clinical equivalence in oncology biosimilar trials Biosimilars/Research | Posted 19/06/2020
Switching from biologicals to biosimilars in Au... Biosimilars/General | Posted 19/06/2020
Generics substitution in Finland: a pharmacy cu... Generics/Research | Posted 19/06/2020
Aurobindo/Sandoz deal falls through, biosimilar... Pharma News | Posted 19/06/2020
Fresenius Kabi’s pegfilgrastim biosimilar accep... Biosimilars/News | Posted 12/06/2020
Use of biosimilar infliximab gives savings for... Biosimilars/Research | Posted 12/06/2020
China accepts IND application for denosumab cop... Biosimilars/News | Posted 12/06/2020
ISOPP publishes a whole host of information on... Biosimilars/General | Posted 12/06/2020
First subjects dosed in Australian phase I stud... Biosimilars/Research | Posted 12/06/2020
NHS lawsuit against Servier Laboratories reache... Policies & Legislation | Posted 12/06/2020
HIV drug Kaletra appears on Russian black market Generics/General | Posted 12/06/2020
Aurobindo Pharma receives FDA approval for thre... Generics/News | Posted 12/06/2020
WHO prequalifies first rituximab biosimilar Biosimilars/General | Posted 05/06/2020
EMA recommends approval of trastuzumab biosimil... Biosimilars/News | Posted 05/06/2020
Fresenius Kabi signs marketing agreement for ad... Pharma News | Posted 05/06/2020
Teva launches rituximab biosimilar Truxima in US Biosimilars/News | Posted 05/06/2020
Biosimilar Awareness Week in Australia Biosimilars/General | Posted 05/06/2020
Turkey 2016 COVER V16E31DG
Samsung Bioepis releases data on trastuzumab an... Biosimilars/Research | Posted 05/06/2020
Patients’ perceptions of switching to biosimilars Biosimilars/Research | Posted 05/06/2020
FDA to hold public meeting on its user fee prog... Policies & Legislation | Posted 05/06/2020
Switching V19A17
Safety of switching between reference products... Biosimilars/Research | Posted 29/05/2020
Success for Celltrion in Japan and Samsung Bioe... Pharma News | Posted 29/05/2020
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NON-BIOLOGICAL COMPLEX DRUGS

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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FDA approves 40 mg follow-on version of glatira... Non‐Biological Complex Drugs/News | Posted 09/03/2018
Mylan launches first follow-on glatiramer aceta... Non‐Biological Complex Drugs/News | Posted 15/02/2018
Biosimilars and follow-on NBCDs for MS in Europ... Non‐Biological Complex Drugs/Research | Posted 19/01/2018
Impax announces FDA approval of follow-on sevel... Non‐Biological Complex Drugs/News | Posted 17/11/2017
FDA approves follow-on version of sevelamer Non‐Biological Complex Drugs/News | Posted 30/06/2017
Challenges in the regulation of NBCDs Non‐Biological Complex Drugs/Research | Posted 12/05/2017
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
Follow-up studies needed to ensure safety for f... Non‐Biological Complex Drugs/Research | Posted 31/03/2017
Warning letter causes delays for follow-on glat... Non‐Biological Complex Drugs/News | Posted 17/03/2017
Is the EU ready for non-biological complex drug... Non‐Biological Complex Drugs/Research | Posted 03/03/2017
Follow-on versions of glatiramer acetate in Rus... Non‐Biological Complex Drugs/News | Posted 24/02/2017
Non-biological complex drugs and pharmacopoeias Non‐Biological Complex Drugs/Research | Posted 10/02/2017
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
FDA to set up abbreviated pathway for complex p... Non‐Biological Complex Drugs/Polices & Legislation | Posted 21/10/2016
Challenges in the assessment of ophthalmic emul... Non‐Biological Complex Drugs/Reports | Posted 07/10/2016
Cancer lab to evaluate bioequivalence of nanosi... Non‐Biological Complex Drugs/News | Posted 23/09/2016
A conference on ‘Equivalence of Complex Drug Pr... Non‐Biological Complex Drugs/News | Posted 09/09/2016
Collaboration to introduce nanotechnologies in... Non‐Biological Complex Drugs/News | Posted 26/08/2016
Iron carbohydrate follow-on NBCDs Non‐Biological Complex Drugs/Reports | Posted 12/08/2016
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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