EC workshop on biosimilars aims to improve uptake

Posted 19/01/2018

With the aim of encouraging equitable and timely access to biosimilars in Europe, the European Commission (EC) held its third workshop on biosimilars in Brus...

Biosimilars applications under review by EMA –... Biosimilars/General | Posted 19/01/2018
Additional clinical data for Cinfa’s pegfilgras... Biosimilars/Research | Posted 19/01/2018
Treatment of chronic myeloid leukaemia patients... Generics/Research | Posted 19/01/2018
FDA approves follow-on insulin lispro Admelog Biosimilars/News | Posted 19/01/2018
France fines J&J 25 million Euro for blocki... Generics/General | Posted 19/01/2018
Mylan appeals to FDA: no approval for generic A... Generics/News | Posted 19/01/2018
Top 10 most read GaBI Online articles in 2017 Pharma News | Posted 12/01/2018
Switching failures with biosimilar etanercept Biosimilars/Research | Posted 12/01/2018
FDA approves biosimilar infliximab Ixifi Biosimilars/News | Posted 12/01/2018
Generics applications under review by EMA – Jan... Generics/General | Posted 12/01/2018
The Greek problem of generics pricing Generics/Research | Posted 12/01/2018
FDA updates its list of drugs without generics Guidelines | Posted 12/01/2018
Bevacizumab similar biologic launched in India Biosimilars/News | Posted 12/01/2018
FDA approves trastuzumab biosimilar Ogivri Biosimilars/News | Posted 05/01/2018
Reimbursement for oncology biosimilars in the US Biosimilars/Research | Posted 05/01/2018
Roche sues Pfizer over Herceptin biosimilar Biosimilars/General | Posted 05/01/2018
Impact of follow-on biological products in the... Biosimilars/Research | Posted 05/01/2018
Jan Aushadhi and affordability and accessibilit... Generics/Research | Posted 05/01/2018
J&J drops lawsuit against Samsung Bioepis o... Pharma News | Posted 05/01/2018
EC publishes biosimilar Q&A document for pa... Biosimilars/General | Posted 08/12/2017
Hospital specialists and pharmacists surveyed a... Biosimilars/Research | Posted 08/12/2017
EMA accepts applications for pegfilgrastim and... Biosimilars/News | Posted 08/12/2017
Mylan/Aspen launch generic busulfan injection Generics/News | Posted 08/12/2017
Positive phase III switching results for Celltr... Biosimilars/Research | Posted 08/12/2017
EC approval for trastuzumab biosimilar Ontruzant Biosimilars/News | Posted 01/12/2017
Switching from reference infliximab to CT P13 i... Biosimilars/Research | Posted 01/12/2017
South Africa approves first non-originator biol... Biosimilars/News | Posted 01/12/2017
Drugmakers waking up to potential value of bran... Generics/News | Posted 01/12/2017
Generic metformin bioequivalent in healthy volu... Generics/Research | Posted 01/12/2017
Biosimilars in oncology in Europe Biosimilars/Research | Posted 01/12/2017
Biosimilars of palivizumab Biosimilars/General | Posted 01/12/2017
EMA approval for bevacizumab biosimilar Mvasi Biosimilars/News | Posted 24/11/2017
Switching to biosimilar infliximab in IBD patients Biosimilars/Research | Posted 24/11/2017
REMS issues come under FDA spotlight Generics/General | Posted 24/11/2017
Perceptions and attitudes towards generics in S... Generics/Research | Posted 24/11/2017
Biosimilars in oncology in the US Biosimilars/Research | Posted 24/11/2017
FDA tentatively approves pemetrexed generic Generics/News | Posted 24/11/2017
The importance of EPARs Reports | Posted 17/11/2017
EC approval for adalimumab biosimilar Cyltezo Biosimilars/News | Posted 17/11/2017
Loss of efficacy after switching to biosimilar... Biosimilars/Research | Posted 17/11/2017


Biosimilars and follow-on NBCDs for MS in Europe, the US and Canada Posted 19/01/2018

The advent of biological medicines has significantly transformed the landscap...


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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
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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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