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Regulation of biologicals in Colombia

Posted 20/04/2018

Since the introduction of Decree 1782 Colombia has been moving towards a new regulatory landscape for biologicals (productos bioterapéuticos) and similar bi...

FDA rejects Celltrion/Teva’s rituximab and tras... Biosimilars/News | Posted 20/04/2018

Interchangeability for biosimilars Reports | Posted 20/04/2018

Switchback rates between generic and brand-name... Generics/Research | Posted 20/04/2018

Afucosylated biosimilars: the path to matching... Biosimilars/Research | Posted 20/04/2018

CFDA to come under national market supervision... Policies & Legislation | Posted 20/04/2018

Naming is an obstacle to the use of biosimilars... Biosimilars/Research | Posted 20/04/2018

Generics companies defend against illegal ‘pay-... Generics/General | Posted 20/04/2018

Obstacles to the use of biosimilars in the US Biosimilars/Research | Posted 13/04/2018

Guidelines for biosimilars around the world Reports | Posted 13/04/2018

EMA approval for infliximab biosimilar Zessly Biosimilars/News | Posted 13/04/2018

Three US states pass biosimilar substitution bills Policies & Legislation | Posted 13/04/2018

EMA opens public consultation on GMP non-compli... Guidelines | Posted 13/04/2018

Strategies for development and validation of ne... Biosimilars/Research | Posted 13/04/2018

Australia’s Mayne Pharma launches generic antib... Generics/News | Posted 13/04/2018

Stada resubmits biosimilar pegfilgrastim but st... Pharma News | Posted 13/04/2018

ACI 9th Annual Summit on Biosimilars 2018 Conferences | Posted 13/04/2018

Biosimilar policies in Europe Biosimilars/Research | Posted 06/04/2018

EMA approval for trastuzumab biosimilar Kanjinti Biosimilars/News | Posted 06/04/2018

FDA approach to retrospectively naming biologicals Reports | Posted 06/04/2018

Etanercept biosimilar SB4 less immunogenic than... Biosimilars/Research | Posted 06/04/2018

Portugal increases use of generics for treatmen... Generics/Research | Posted 06/04/2018

NGO urges HIV drug patent application to be den... Generics/General | Posted 06/04/2018

FDA releases 52 new and revised bioequivalence... Guidelines | Posted 06/04/2018

Korea’s CJ Healthcare shares biosimilar technol... Pharma News | Posted 06/04/2018

Spanish gastroenterologists update biosimilar p... Biosimilars/Research | Posted 30/03/2018

Insulin biosimilar Semglee gains EC and Austral... Biosimilars/News | Posted 30/03/2018

FDA approach to prospectively naming biologicals Reports | Posted 30/03/2018

Government policies to maximize social benefit... Biosimilars/Research | Posted 30/03/2018

Biosimilar deals for Hikma and Lupin Pharma News | Posted 30/03/2018

Pharmaceuticals and products liability litigation Generics/Research | Posted 30/03/2018

Green Shield Canada preferentially lists biosim... Policies & Legislation | Posted 30/03/2018

GSK fined GBP 37.6 million in pay-for-delay appeal Generics/News | Posted 30/03/2018

FDA update on naming biologicals Reports | Posted 23/03/2018

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

FDA issues guidance on co-crystals and impurities Guidelines | Posted 23/03/2018

PK and PD comparison between rituximab biosimil... Biosimilars/Research | Posted 23/03/2018

Lack of confidence in biosimilars slowing uptak... Reports | 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

Legal and promotional wars being waged against... Reports | Posted 16/03/2018

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NON-BIOLOGICAL COMPLEX DRUGS

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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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

Switchback rates between generic and brand-name...Generics/Research | Posted 20/04/2018
Generics companies defend against illegal ‘pay-...Generics/General | Posted 20/04/2018
Australia’s Mayne Pharma launches generic antib...Generics/News | Posted 13/04/2018
Portugal increases use of generics for treatmen...Generics/Research | Posted 06/04/2018

Afucosylated biosimilars: the path to matching...Biosimilars/Research | Posted 20/04/2018
Naming is an obstacle to the use of biosimilars...Biosimilars/Research | Posted 20/04/2018
Obstacles to the use of biosimilars in the USBiosimilars/Research | Posted 13/04/2018
Strategies for development and validation of ne...Biosimilars/Research | Posted 13/04/2018

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