Gulf countries discuss global harmonization of biosimilars

Posted 15/03/2019

The regulation, approval and use of biosimilars is subject to global debate. Policies and regulations differ from country to country which can lead to confus...

Comparison of Brazilian regulations for follow-... Biosimilars/Research | Posted 15/03/2019
China approves rituximab copy biological Biosimilars/News | Posted 15/03/2019
UK’s NICE recommends pertuzumab with biosimilar... Biosimilars/News | Posted 15/03/2019
Copy biologicals approved in China Biosimilars/General | Posted 15/03/2019
Trastuzumab biosimilar PF 05280014 non-inferior... Biosimilars/Research | Posted 15/03/2019
New safety requirements for EU medicines Policies & Legislation | Posted 15/03/2019
Escalating prices of generic drugs in the US Generics/Research | Posted 15/03/2019
Impact of proposed changes to FDA approach to b... Biosimilars/Research | Posted 08/03/2019
EC approval for bevacizumab biosimilar Zirabev Biosimilars/News | Posted 08/03/2019
Two more countries added to EU-US mutual recogn... Policies & Legislation | Posted 08/03/2019
Positive phase I results for Mycenax’s tocilizu... Biosimilars/Research | Posted 08/03/2019
Pilot procurement scheme in China cuts drug prices Generics/General | Posted 08/03/2019
Green Shield Canada’s biosimilar switch pilot a... Biosimilars/General | Posted 08/03/2019
Mandatory and non-mandatory switching for biosi... Biosimilars/Research | Posted 01/03/2019
Monoclonal antibody copy biologicals accepted f... Biosimilars/News | Posted 01/03/2019
Positive phase III results for rituximab biosim... Biosimilars/Research | Posted 01/03/2019
The 700-dollar vitamin: excessive generics pric... Generics/Research | Posted 01/03/2019
Australia plans reform of its generics authoriz... Policies & Legislation | Posted 01/03/2019
Pfizer drops five preclinical biosimilar progra... Biosimilars/General | Posted 01/03/2019
USP action plan for generics and FDA new innova... Generics/General | Posted 01/03/2019
Mylan launches Advair generic at 70% discount Generics/News | Posted 01/03/2019
Questions over DANBIO relevance for non-medical... Biosimilars/Research | Posted 22/02/2019
EC approval for pegfilgrastim biosimilar Fulphila Biosimilars/News | Posted 22/02/2019
UK pharmacists gain powers to address drug shor... Policies & Legislation | Posted 22/02/2019
Biosimilar teriparatide approved for the treatm... Biosimilars/Research | Posted 22/02/2019
Sandoz makes biological deal in China Pharma News | Posted 22/02/2019
Three FDA approvals for Glenmark as it enters U... Biosimilars/News | Posted 22/02/2019
Safety surveillance of bevacizumab biosimilar (... Generics/Research | Posted 15/02/2019
PanGen gains Malaysian approval for epoetin alf... Biosimilars/News | Posted 15/02/2019
European regulatory framework for approval of b... Generics/Research | Posted 15/02/2019
45 US states have passed biosimilar substitutio... Policies & Legislation | Posted 15/02/2019
Impact of generic reference pricing on candesar... Generics/Research | Posted 15/02/2019
Zydus gets FDA approval for skin, heart and aci... Generics/News | Posted 15/02/2019
Long-term stability of trastuzumab biosimilar u... Biosimilars/Research | Posted 08/02/2019
EMA approval for adalimumab biosimilars Idacio... Biosimilars/News | Posted 08/02/2019
Barriers and facilitators to biosimilar prescri... Biosimilars/Research | Posted 08/02/2019
Australia’s PBAC recommends substitution of ada... Biosimilars/News | Posted 08/02/2019
India tightens regulation on generics manufactu... Policies & Legislation | Posted 08/02/2019
Fuji Pharma acquires stake in Alvotech Pharma News | Posted 08/02/2019
Australia’s TGA will keep same names for biolog... Policies & Legislation | Posted 01/02/2019
Tanvex BioPharma submits filgrastim biosimilar... Biosimilars/News | Posted 01/02/2019


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