Top 10 most read GaBI Online articles in 2018

Posted 18/01/2019

A review of the important events for biosimilars during 2018 are presented in this article. Some of the most memorable events for biosimilars in 2018 were th...

CKD Pharma’s darbepoetin alfa biosimilar launch... Biosimilars/News | Posted 18/01/2019
EMA continues to be open to alternative clinica... Biosimilars/Research | Posted 18/01/2019
Safety of brand-name and generic angiotensin II... Generics/Research | Posted 18/01/2019
Positive phase III results for rituximab biosim... Biosimilars/Research | Posted 18/01/2019
Celltrion wins patent suit in Japan over trastu... Biosimilars/General | Posted 18/01/2019
Medicines for Europe 15th Legal Affairs Conference Conferences | Posted 18/01/2019
Medicines for Europe 17th Biosimilar Medicines... Conferences | Posted 18/01/2019
EMA approval for bevacizumab biosimilar Zirabev Biosimilars/News | Posted 11/01/2019
Long-term follow-up of switching to biosimilar... Biosimilars/Research | Posted 11/01/2019
Trastuzumab and agalsidase beta biosimilars lau... Biosimilars/News | Posted 11/01/2019
Biosimilars makers in Canada to launch patient... Biosimilars/General | Posted 11/01/2019
Sandoz to launch epinephrine in early 2019 at a... Generics/News | Posted 11/01/2019
WHO should finalize its BQ guidance Biosimilars/General | Posted 14/12/2018
British diabetologists issues position statemen... Biosimilars/General | Posted 14/12/2018
Biosimilars launched in the US at a significant... Biosimilars/News | Posted 14/12/2018
Five more countries added to EU-US mutual recog... Policies & Legislation | Posted 14/12/2018
Positive results for adalimumab and etanercept... Biosimilars/Research | Posted 14/12/2018
FDA approves drug for cancers with specific bio... Generics/News | Posted 14/12/2018
FDA approves first rituximab biosimilar Truxima Biosimilars/News | Posted 07/12/2018
Boehringer Ingelheim and Sandoz abandon biosimi... Biosimilars/General | Posted 07/12/2018
Positive results for Chinese rituximab and tras... Biosimilars/Research | Posted 07/12/2018
Way cleared in US for Suboxone and Zytiga generics Generics/General | Posted 07/12/2018
Positive phase I results for Fresenius Kabi’s p... Biosimilars/Research | Posted 07/12/2018
Glenmark gains FDA approval for MS and pneumoni... Generics/News | Posted 07/12/2018
EC approval for pegfilgrastim biosimilars Pelme... Biosimilars/News | Posted 30/11/2018
Switching from reference products to biosimilar... Biosimilars/Research | Posted 30/11/2018
Effectiveness of chronic hepatitis C treatment... Generics/Research | Posted 30/11/2018
FDA approves more generics in 2018 than any oth... Generics/General | Posted 30/11/2018
Comparative results for CT-P10 in low-tumour bu... Biosimilars/Research | Posted 30/11/2018
Patient, health and trade groups say USMCA will... Policies & Legislation | Posted 30/11/2018
Access! 2019 AAM Annual Meeting Conferences | Posted 30/11/2018
Safety of originator and biosimilar epoetin alf... Biosimilars/Research | Posted 23/11/2018
Insulin glargine biosimilars launched in UK and... Biosimilars/News | Posted 23/11/2018
FDA strengthens and modernizes inspections for... Policies & Legislation | Posted 23/11/2018
Tanvex BioPharma submits filgrastim biosimilar... Biosimilars/News | Posted 23/11/2018
Positive phase III data for adalimumab biosimil... Biosimilars/Research | Posted 23/11/2018


FDA issues final guidance on liposome drug products Posted 27/04/2018

On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft...


FDA approves 40 mg follow-on version of glatira... Non‐Biological Complex Drugs/News | Posted 09/03/2018
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