Establishing interchangeability for biosimilars

Posted 08/12/2017

Hans Ebbers, Regulatory Project Leader of the Pharmacotherapeutic Group III at the Medicines Evaluation Board (MEB/CBG) in The Netherlands discussed how to e...

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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
Adalimumab and trastuzumab biosimilars approved... Biosimilars/News | Posted 17/11/2017
Opportunities and challenges for biosimilars in... Biosimilars/Research | Posted 17/11/2017
UK launches campaign to promote research on bio... Biosimilars/General | Posted 17/11/2017
Kenya needs to increase use of generics to comb... Generics/General | Posted 17/11/2017
CBI’s 13th Biosimilars Summit 2018 Conferences | Posted 17/11/2017
Biosimilars in the European Union Reports | Posted 10/11/2017
Physicians urge CMS to adopt unique billing cod... Policies & Legislation | Posted 10/11/2017
Mergers could be causing price increases for ge... Generics/Research | Posted 10/11/2017
Phase III switching data support long-term effi... Biosimilars/Research | Posted 10/11/2017
India updates its similar biologics guideline Guidelines | Posted 10/11/2017
EMA approval for tacrolimus generic Generics/News | Posted 10/11/2017
Humira deal could cost CMS US$1.48 billion Biosimilars/News | Posted 10/11/2017
Physicochemical and biological characterization... Biosimilars/Research | Posted 10/11/2017
Australian prescribers’ views on biologicals na... Biosimilars/Research | Posted 03/11/2017
EMA accepts biosimilar pegfilgrastim applicatio... Biosimilars/News | Posted 03/11/2017
Biosimilar insulins – reducing the cost of diab... Biosimilars/Research | Posted 03/11/2017
New use for old generic could treat rare cardio... Generics/Research | Posted 03/11/2017
Hospira to pay Amgen US$70 million for epoetin... Biosimilars/General | Posted 03/11/2017
Texan judge invalidates Restasis patents Generics/General | Posted 03/11/2017
European perspective on biosimilars Biosimilars/Research | Posted 27/10/2017
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NON-BIOLOGICAL COMPLEX DRUGS

Impax announces FDA approval of follow-on sevelamer carbonate Posted 17/11/2017

US generics maker Impax Laboratories (Impax) announced on 23 October 2017 tha...

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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
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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