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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

Boehringer wins access to Humira documents as J... Pharma News | Posted 08/03/2019

Positive phase I results for Mycenax’s tocilizu... Biosimilars/Research | Posted 08/03/2019

FDA plans to advance development of complex gen... Guidelines | 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

Spanish pharmacists publish biosimilar position... Reports | 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

FDA issues new guidance for accelerated pathway... Guidelines | 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

Samsung Bioepis makes deals for copy biological... Pharma News | Posted 15/02/2019

ICH proposes harmonization of standards for gen... Guidelines | 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

FDA to improve Orange Book: issues draft guidan... Guidelines | Posted 08/02/2019

India tightens regulation on generics manufactu... Policies & Legislation | Posted 08/02/2019

FDA approves Lupin’s generic clobazam and Dr Re... Generics/News | 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

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NON-BIOLOGICAL COMPLEX DRUGS

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

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Country Focus

First posted: 11 May 2010 Concerning the views on biosimilars in The Ne... Posted 16/04/2015
First posted: 11 April 2012 Concerning the generics market in Austria,... Posted 16/04/2015

All countries

Generics News Research General

Escalating prices of generic drugs in the USGenerics/Research | Posted 15/03/2019
Pilot procurement scheme in China cuts drug pricesGenerics/General | Posted 08/03/2019
Mylan launches Advair generic at 70% discountGenerics/News | Posted 01/03/2019
USP action plan for generics and FDA new innova...Generics/General | Posted 01/03/2019

Comparison of Brazilian regulations for follow-...Biosimilars/Research | Posted 15/03/2019
China approves rituximab copy biologicalBiosimilars/News | Posted 15/03/2019
UK’s NICE recommends pertuzumab with biosimilar...Biosimilars/News | Posted 15/03/2019
Copy biologicals approved in ChinaBiosimilars/General | Posted 15/03/2019

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