FDA update on naming biologicals

Posted 23/03/2018

Dr Kellie Taylor, Associate Director of the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology at the U...

Trastuzumab biosimilar Ontruzant launched in th... Biosimilars/News | Posted 23/03/2018
Portugal saves money with increased use of card... Generics/Research | Posted 23/03/2018
Yoshindo and Lupin’s etanercept biosimilar comp... Biosimilars/Research | Posted 23/03/2018
PK and PD comparison between rituximab biosimil... Biosimilars/Research | Posted 23/03/2018
US introduces bill to close drug patent loophole Policies & Legislation | Posted 23/03/2018
DIA 2018 Global Annual Meeting Conferences | Posted 23/03/2018
Follow-on biologicals and extrapolation in Brazil Biosimilars/Research | Posted 16/03/2018
Insulin glargine biosimilar gains South Korean... Biosimilars/News | Posted 16/03/2018
Biosimilar policies around the globe Biosimilars/Research | Posted 16/03/2018
Michigan latest state to pass biosimilars subst... Policies & Legislation | Posted 16/03/2018
Barriers to HIV generics in the US Generics/Research | Posted 16/03/2018
US drug contracting system is ‘rigged’ against... Biosimilars/General | Posted 16/03/2018
Lupin launches generic memantine XR capsules in... Generics/News | Posted 16/03/2018
ASCO issues position statement on biosimilars i... Biosimilars/Research | Posted 09/03/2018
Bioequivalence of brand-name and two generic ta... Generics/Research | Posted 09/03/2018
Trastuzumab biosimilar launched in South Korea Biosimilars/News | Posted 09/03/2018
Use and cost of biologicals for cancer treatmen... Biosimilars/Research | Posted 09/03/2018
Ireland’s National Biosimilar Medicines Policy... Policies & Legislation | Posted 09/03/2018
Cadila and Kalbe advancing biosimilar ambitions Biosimilars/General | Posted 09/03/2018
Joint 24th Medicines for Europe and 21st IGBA A... Conferences | Posted 09/03/2018
Kissei/JCR’s darbepoetin alfa biosimilar shows... Biosimilars/Research | Posted 02/03/2018
US government tries to address the increasing c... Generics/General | Posted 02/03/2018
Obstacles to biosimilars uptake in the US Reports | Posted 02/03/2018
Mylan and Revance team up for botox biosimilar Pharma News | Posted 02/03/2018
Adverse outcomes for elderly using generic vers... Generics/Research | Posted 02/03/2018
EC approval for trastuzumab biosimilar Herzuma Biosimilars/News | Posted 02/03/2018
Pharmacy-mediated substitution: the global poli... Biosimilars/Research | Posted 02/03/2018
Generics versus biosimilars: pricing and usage-... Biosimilars/Research | Posted 23/02/2018
Biosimilars of denosumab Biosimilars/General | Posted 23/02/2018
Canada’s generics industry to cut prices by up... Generics/General | Posted 23/02/2018
Persistence with generic imatinib in CML patients Generics/Research | Posted 23/02/2018
Etanercept switching study investigates non-man... Biosimilars/Research | Posted 23/02/2018
EBE reveals Europe’s biosimilar pricing and rei... Biosimilars/Research | Posted 15/02/2018
EMA approval for biosimilar insulin glargine Se... Biosimilars/News | Posted 15/02/2018
Quality and clinical performance of biopharmace... Biosimilars/Research | Posted 15/02/2018
Building confidence in biosimilars Reports | Posted 15/02/2018
Europe calls for more drugs repurposing Generics/General | Posted 15/02/2018
Efficacy and safety of generic imatinib after s... Generics/Research | Posted 15/02/2018
Zarxio reveals all: the US biosimilars market Biosimilars/Research | Posted 09/02/2018
Comments on TGA’s modified approach to naming b... Policies & Legislation | Posted 09/02/2018


FDA approves 40 mg follow-on version of glatiramer acetate Posted 09/03/2018

Sandoz, the generics division of Novartis, announced on 13 February 2018 the...


Mylan launches first follow-on glatiramer aceta... Non‐Biological Complex Drugs/News | Posted 15/02/2018
Biosimilars and follow-on NBCDs for MS in Europ... Non‐Biological Complex Drugs/Research | Posted 19/01/2018
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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