WHO proposes provisional implementation of biological qualifier

Posted 28/10/2016

The World Health Organization first introduced the concept of a biological qualifier (BQ) for naming biologicals back in 2014. This was followed by a draft p...

Standardizing clinical trials for biosimilars Biosimilars/Research | Posted 28/10/2016
Study design for biosimilar trials Biosimilars/Research | Posted 28/10/2016
Colombia to enforce declaration of public inter... Policies & Legislation | Posted 28/10/2016
Biogen’s infliximab biosimilar gets UK launch Biosimilars/News | Posted 28/10/2016
NOR-SWITCH study finds biosimilar infliximab no... Biosimilars/Research | Posted 21/10/2016
Competition in the generics industry Generics/Research | Posted 21/10/2016
Biosimilars versus generics Biosimilars/Research | Posted 21/10/2016
Pfizer to launch infliximab biosimilar Inflectr... Biosimilars/News | Posted 21/10/2016
Merck launches biosimilars educational resource... Biosimilars/General | Posted 21/10/2016
Mylan agrees to pay fine over EpiPen rebates Generics/News | Posted 21/10/2016
Use of biosimilar anti-TNF in Australia Biosimilars/Research | Posted 14/10/2016
Teva and Celltrion to partner on biosimilars Biosimilars/News | Posted 14/10/2016
Positive phase III results for Mylan’s biosimil... Biosimilars/Research | Posted 14/10/2016
Court rules in favour of Apotex in biosimilars... Biosimilars/General | Posted 14/10/2016
16th Regulatory and Scientific Affairs Conference Conferences | Posted 14/10/2016
10th Pharmacovigilance Conference Conferences | Posted 14/10/2016
EMA accepts application for trastuzumab biosimilar Biosimilars/News | Posted 07/10/2016
Biosimilars in rheumatology Biosimilars/Research | Posted 07/10/2016
Generic antibiotics could be contributing to ba... Generics/Research | Posted 07/10/2016
FDA and industry agree on terms of GDUFA II rea... Policies & Legislation | Posted 07/10/2016
Australia to adopt EMA generics guidelines Guidelines | Posted 07/10/2016
DIA 4th European Biosimilars Conference Conferences | Posted 07/10/2016
FDA approval for Amgen’s adalimumab biosimilar Biosimilars/News | Posted 30/09/2016
Switching may not be suitable for patients with... Biosimilars/Research | Posted 30/09/2016
EU upholds decision to fine Lundbeck for violat... Policies & Legislation | Posted 30/09/2016
Efficacy and safety of biosimilar infliximab in... Biosimilars/Research | Posted 30/09/2016
Australia says etanercept biosimilar can be sub... Biosimilars/News | Posted 30/09/2016
Teva recalls antibiotic and anti-seizure drug Generics/News | Posted 30/09/2016
Biosimilar User Fee Act reauthorization Biosimilars/General | Posted 23/09/2016
Different approaches to bioequivalence trials f... Generics/Research | Posted 23/09/2016
FDA approves biosimilar etanercept Erelzi Biosimilars/News | Posted 23/09/2016
Regulation of biosimilars in Japan Reports | Posted 23/09/2016
Why do generic drug prices keep on rising? Generics/General | Posted 23/09/2016
Positive phase III results for Sandoz etanercep... Biosimilars/Research | Posted 23/09/2016
Canadian approval for etanercept biosimilar Biosimilars/News | Posted 16/09/2016


FDA to set up abbreviated pathway for complex products Posted 21/10/2016

As part of the Generic Drug User Fee Amendments (GDUFA II) reauthorization re...


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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