Biosimilarity does not mean extrapolation of all indications

Posted 28/04/2017

In his presentation at the SMi 3rd Annual Biosimilars USA Conference, Dr Brad Jordan, Director of Global Regulatory and R & D Policy at Amgen, outlined f...

Approaches to assure quality and improve patien... Generics/Research | Posted 28/04/2017
EMA approval for etanercept and rituximab biosi... Biosimilars/News | Posted 28/04/2017
Prospective study finds switching to biosimilar... Biosimilars/Research | Posted 28/04/2017
Fujifilm ramps up biosimilars production as UK... Biosimilars/General | Posted 28/04/2017
Patent challenges hit Actavis and Acorda Generics/News | Posted 28/04/2017
Biosimilarity is not interchangeability Reports | Posted 21/04/2017
Rituximab biosimilar safe in advanced follicula... Biosimilars/Research | Posted 21/04/2017
Advances in ranibizumab and teriparatide biosim... Biosimilars/News | Posted 21/04/2017
Significant price reductions possible for new c... Generics/Research | Posted 21/04/2017
Biosimilars of certolizumab pegol Biosimilars/General | Posted 21/04/2017
Maryland has increased power over drug prices Policies & Legislation | Posted 21/04/2017
Harmonization of requirements for NBCDs across... Biosimilars/Research | Posted 21/04/2017
Indian drug industry faces setbacks in Europe a... Generics/General | Posted 21/04/2017
US pharmacists’ views on the naming and labelli... Biosimilars/Research | Posted 14/04/2017
Trastuzumab biosimilar submitted for approval i... Biosimilars/News | Posted 14/04/2017
Italian study compares epoetin biosimilars and... Biosimilars/Research | Posted 14/04/2017
Generics could cut costs of cancer drugs by ove... Generics/Research | Posted 14/04/2017
FDA commits to success of the generic and biosi... Generics/General | Posted 14/04/2017
Increasing access to biosimilars and generics i... Biosimilars/General | Posted 14/04/2017
The evolution of biosimilars in the US Reports | Posted 07/04/2017
Basal analogue insulin ‘copy biological’ launch... Biosimilars/News | Posted 07/04/2017
Filgrastim follow-on biological has similar eff... Biosimilars/Research | Posted 07/04/2017
Merck KGaA to sell off biosimilars business Pharma News | Posted 07/04/2017
Amgen at the centre of biosimilars disputes Biosimilars/General | Posted 07/04/2017
Marketing authorization for NBCDs in the EU Biosimilars/Research | Posted 07/04/2017
UK authority accuses Actavis UK and Concordia o... Policies & Legislation | Posted 07/04/2017
EC approval for adalimumab biosimilar Amgevita Biosimilars/News | Posted 31/03/2017
The European Pharmacopoeia monographs for bioth... Biosimilars/Research | Posted 31/03/2017
Evolution of scientific research on generic drugs Generics/Research | Posted 31/03/2017
FDA biologicals naming guidance could cost pro... Biosimilars/General | Posted 31/03/2017
India and Argentina call for hepatitis C generics Policies & Legislation | Posted 31/03/2017
Generic antidepressant launched in the US Generics/News | Posted 31/03/2017
Amgen submits trastuzumab biosimilar to EMA Biosimilars/News | Posted 24/03/2017
Study of top-down infliximab use in children wi... Biosimilars/Research | Posted 24/03/2017
Potency of generics of piperacillin/tazobactam Generics/Research | Posted 24/03/2017
Evidence on biosimilar efficacy and safety lead... Biosimilars/Research | Posted 24/03/2017
Australians pay too much for prescription drugs Pharma News | Posted 24/03/2017
EMA and FDA to recognize GMP inspections Policies & Legislation | Posted 24/03/2017
Pharma associations issue position paper on bio... Biosimilars/General | Posted 17/03/2017
Improving efficacy of biologicals without incre... Biosimilars/Research | Posted 17/03/2017
Global settlement clears a pathway for trastuzu... Biosimilars/News | Posted 17/03/2017
Revised Q&As on biosimilars for patients Reports | Posted 17/03/2017


Equivalence of complex drug products Posted 14/04/2017

Complex drug products and their generic (or follow-on) versions was the subje...


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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