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...

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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
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NON-BIOLOGICAL COMPLEX DRUGS

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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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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