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Ensuring a stable supply of APIs in Japan

Posted 09/11/2018

A stable supply of active pharmaceutical ingredients (APIs) is indispensable for a stable supply of finished pharmaceutical products (FPPs). It is also indis...

FDA approves adalimumab and pegfilgrastim biosi... Biosimilars/News | Posted 09/11/2018

Inflectra may not be less expensive than Remica... Biosimilars/Research | Posted 09/11/2018

FDA issues guidance for developers of complex g... Guidelines | Posted 09/11/2018

Phase III study of biosimilar pegfilgrastim con... Biosimilars/Research | Posted 09/11/2018

Teva sues FDA for changing ‘first applicant’ de... Generics/General | Posted 09/11/2018

Brazil to remove backlog for generics Biosimilars/General | Posted 09/11/2018

New Zealand to fund only biosimilar epoetin alfa Policies & Legislation | Posted 09/11/2018

Medicines for Europe 12th Pharmacovigilance Con... Conferences | Posted 09/11/2018

Medicines for Europe 18th Regulatory and Scient... Conferences | Posted 09/11/2018

ACI 10th Annual Summit on Biosimilars 2019 Conferences | Posted 09/11/2018

Adalimumab biosimilars Amgevita and Imraldi lau... Biosimilars/News | Posted 02/11/2018

Clinical and real-world data for switching to b... Biosimilars/Research | Posted 02/11/2018

Individual pathways for development of complex... Generics/Research | Posted 02/11/2018

Merck gains US infliximab contract but drops in... Biosimilars/General | Posted 02/11/2018

FDA proposes standardization of generics standards Generics/General | Posted 02/11/2018

EU-US mutual recognition extended to include Po... Policies & Legislation | Posted 02/11/2018

Real-life clinical effectiveness of Razumab in... Biosimilars/Research | Posted 02/11/2018

Trastuzumab similar biologic Hervycta launched... Biosimilars/News | Posted 02/11/2018

Mylan gains nod for Ogivri and launches Hulio i... Biosimilars/News | Posted 26/10/2018

FDA to refer citizen petitions attempting to de... Guidelines | Posted 26/10/2018

Originator biologicals and biosimilars under at... Biosimilars/General | Posted 26/10/2018

Mass spectrometry comparison of Remicade and Re... Biosimilars/Research | Posted 26/10/2018

Momenta to reduce its biosimilars programmes Pharma News | Posted 26/10/2018

Switching to etanercept biosimilar SB4 safe and... Biosimilars/Research | Posted 26/10/2018

FDA reviews adalimumab biosimilar SB5 Biosimilars/News | Posted 26/10/2018

China approves first ambrisentan generic Generics/News | Posted 26/10/2018

Expediting FDA approvals for biosimilars Biosimilars/Research | Posted 19/10/2018

FDA advisers recommend approval of rituximab bi... Biosimilars/News | Posted 19/10/2018

Sustainability of biosimilars in Europe Reports | Posted 19/10/2018

Platelet reactivity with generic and brand-name... Generics/Research | Posted 19/10/2018

Australia encouraging biosimilars and mandating... Policies & Legislation | Posted 19/10/2018

Biosimilar partnerships for Alvotech and Pall B... Pharma News | Posted 19/10/2018

Teva launches generic tadalafil but delays laun... Generics/News | Posted 19/10/2018

Phase III trial for subcutaneous Remsima completed Biosimilars/Research | Posted 19/10/2018

Comments on FDA’s public meeting on biosimilars Biosimilars/General | Posted 12/10/2018

Two darbepoetin alfa biosimilars submitted to J... Biosimilars/News | Posted 12/10/2018

Reasons for switching to biosimilars and immuno... Biosimilars/Research | Posted 12/10/2018

Free prescriptions do not always increase use o... Generics/Research | Posted 12/10/2018

Mundipharma buys Spanish biosimilars maker Cinf... Pharma News | Posted 12/10/2018

European approval for fluticasone/salmeterol an... Generics/News | Posted 12/10/2018

FDA approves first drug via Competitive Generic... Generics/General | Posted 12/10/2018

EMA aims to improve the availability of medicin... Policies & Legislation | Posted 12/10/2018

Stakeholder perspectives on biosimilars in onco... Biosimilars/Research | Posted 05/10/2018

EC approval for adalimumab and pegfilgrastim bi... Biosimilars/News | Posted 05/10/2018

Limited distribution networks found to be antic... Generics/Research | Posted 05/10/2018

Biosimilars no longer eligible for parallel pro... Policies & Legislation | Posted 05/10/2018

Hospitals launch non-profit generics company Generics/General | Posted 05/10/2018

Pharmacokinetics of CT-P6 in patients with HER2... Biosimilars/Research | Posted 05/10/2018

FDA releases new guidance to speed up generics... Guidelines | Posted 05/10/2018

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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

Teva sues FDA for changing ‘first applicant’ de...Generics/General | Posted 09/11/2018
Ensuring a stable supply of APIs in JapanGenerics/Research | Posted 09/11/2018
Individual pathways for development of complex...Generics/Research | Posted 02/11/2018
FDA proposes standardization of generics standardsGenerics/General | Posted 02/11/2018

Inflectra may not be less expensive than Remica...Biosimilars/Research | Posted 09/11/2018
Phase III study of biosimilar pegfilgrastim con...Biosimilars/Research | Posted 09/11/2018
Real-life clinical effectiveness of Razumab in...Biosimilars/Research | Posted 02/11/2018
FDA approves adalimumab and pegfilgrastim biosi...Biosimilars/News | Posted 09/11/2018

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