Danish infliximab switching study shows no difference

Posted 19/05/2017

A study published by researchers from Denmark has found that switching from originator to biosimilar infliximab has ‘no negative impact on disease activity’...

more
Post-marketing experience with IBD biosimilars Biosimilars/Research | Posted 19/05/2017
Biosimilars applications under review by EMA –... Biosimilars/General | Posted 19/05/2017
Concerns over change to generics prescribing in... Generics/General | Posted 19/05/2017
Product-specific pharmacovigilance Reports | Posted 19/05/2017
Positive phase I results for Cinfa’s pegfilgras... Biosimilars/News | Posted 19/05/2017
Apotex petitions FDA over Neulasta biosimilars Guidelines | Posted 19/05/2017
WHO to launch prequalification programme for bi... Biosimilars/General | Posted 12/05/2017
Accountability, safety and competition in biolo... Biosimilars/Research | Posted 12/05/2017
Second infliximab biosimilar to be launched in... Biosimilars/News | Posted 12/05/2017
Generics applications under review by EMA – Apr... Generics/General | Posted 12/05/2017
Sound pharmacy practices for biosimilars Reports | Posted 12/05/2017
US introduces two new bills to promote generics Policies & Legislation | Posted 12/05/2017
Safe switching for biosimilars Reports | Posted 05/05/2017
Computer modelling for glycoengineering of bios... Biosimilars/Research | Posted 05/05/2017
FDA approves biosimilar infliximab Renflexis Biosimilars/News | Posted 05/05/2017
Reference pricing for generics in Switzerland Generics/Research | Posted 05/05/2017
How will the timing of BPCI Act 180-day notice... Policies & Legislation | Posted 05/05/2017
First Advair generic launched in the US Generics/News | Posted 05/05/2017
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
more

NON-BIOLOGICAL COMPLEX DRUGS

Challenges in the regulation of NBCDs Posted 12/05/2017

Author Leonie Hussaarts and colleagues discuss in a white paper the regulator...

more


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
more