Home - GaBI Online - Generics and Biosimilars Initiative

Canadian IBD charity updates biosimilar position statement

Posted 13/09/2019

On 5 September 2019, Crohn’s and Colitis Canada announced that it had updated its position statement on the use of biosimilars for inflammatory bowel disease...

Herzuma gains Japanese approval for three-week... Biosimilars/News | Posted 13/09/2019

TRIPS flexibilities: current and future use in... Generics/Research | Posted 13/09/2019

More positive phase III results for rituximab b... Biosimilars/Research | Posted 13/09/2019

Huons enters biosimilar market while private eq... Pharma News | Posted 13/09/2019

FDA organizes workshop on complex generics Guidelines | Posted 13/09/2019

Clinical comparability between rituximab biosim... Generics/Research | Posted 13/09/2019

Revance Therapeutics focus on its own Botox bio... Biosimilars/News | Posted 13/09/2019

Challenges for European pharmacovigilance Reports | Posted 06/09/2019

Teriparatide biosimilar Terrosa launched in Europe Biosimilars/News | Posted 06/09/2019

Improving access to medicines: the Doha Declara... Generics/Research | Posted 06/09/2019

Praise for Canada’s BC after it adopts biosimil... Policies & Legislation | Posted 06/09/2019

Switching from reference to biosimilar inflixim... Biosimilars/Research | Posted 06/09/2019

Court rules Amgen’s patents on Enbrel are valid... Biosimilars/General | Posted 06/09/2019

Positive results for Bio-Thera’s arthritis copy... Biosimilars/Research | Posted 06/09/2019

Mylan launches adalimumab biosimilar Hulio in S... Biosimilars/News | Posted 06/09/2019

Perceptions of biosimilars among US cancer pati... Biosimilars/Research | Posted 30/08/2019

Heparin biosimilar to be marketed in Canada Biosimilars/News | Posted 30/08/2019

Momenta drops Humira biosimilar development Biosimilars/General | Posted 30/08/2019

China issues list of generics needed in the cou... Generics/General | Posted 30/08/2019

Alvotech and Cipla Gulf partnership announced Pharma News | Posted 30/08/2019

Comparison of darbepoetin alfa and epoetin alfa... Biosimilars/Research | Posted 30/08/2019

Patent challenges in the SADC region Generics/Research | Posted 30/08/2019

Trastuzumab biosimilar to be distributed by Mu... Biosimilars/News | Posted 30/08/2019

Mylan launches first trastuzumab biosimilar in... Biosimilars/News | Posted 23/08/2019

Samsung Bioepis starts phase III trial for ecul... Biosimilars/News | Posted 23/08/2019

Australia approves three biosimilars in first h... Biosimilars/General | Posted 23/08/2019

China audits drug companies Policies & Legislation | Posted 23/08/2019

Agreement between Hikma and Civica to reduce US... Pharma News | Posted 23/08/2019

Generic irbesartan is safe and effective, shows... Generics/Research | Posted 23/08/2019

Safety of SC form of infliximab biosimilar CT-P13 Biosimilars/Research | Posted 23/08/2019

FDA approves Farxiga generic Generics/News | Posted 23/08/2019

FDA approves adalimumab biosimilar Hadlima Biosimilars/News | Posted 16/08/2019

Korean firms to launch biosimilars in Japan des... Biosimilars/News | Posted 16/08/2019

WHO essential medicines list: new lung cancer m... Pharma News | Posted 16/08/2019

Biosimilars applications under review by EMA –... Biosimilars/General | Posted 16/08/2019

Positive phase III results for bevacizumab copy... Biosimilars/Research | Posted 16/08/2019

Prices for infectious disease treatments and ho... Generics/Research | Posted 16/08/2019

IPRP expands and all EU Member States now inclu... Policies & Legislation | Posted 16/08/2019

Extensive characterization of biosimilars: a pe... Biosimilars/Research | Posted 16/08/2019

Distinct suffixes will aid biosimilar competiti... Biosimilars/Research | Posted 09/08/2019

EMA accepts first application for Chinese-made... Biosimilars/News | Posted 09/08/2019

Bill introduced in US to cut insulin prices Policies & Legislation | Posted 09/08/2019

South Korea’s Celltrion to sell directly to Aus... Biosimilars/General | Posted 09/08/2019

Rituximab copy biological accepted for review i... Biosimilars/News | Posted 09/08/2019

Real-world data on switching of etanercept bios... Biosimilars/Research | Posted 09/08/2019

Prestige and Pharmapark make deal for trastuzu... Pharma News | Posted 09/08/2019

Certara technology achieves first FDA virtual... Generics/News | Posted 09/08/2019

FDA approves rituximab biosimilar Ruxience Generics/News | Posted 02/08/2019

Long-term safety results for adalimumab biosimilar Biosimilars/Research | Posted 02/08/2019

previous next

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

previous next

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

Clinical comparability between rituximab biosim...Generics/Research | Posted 13/09/2019
TRIPS flexibilities: current and future use in...Generics/Research | Posted 13/09/2019
Improving access to medicines: the Doha Declara...Generics/Research | Posted 06/09/2019
China issues list of generics needed in the cou...Generics/General | Posted 30/08/2019

Herzuma gains Japanese approval for three-week...Biosimilars/News | Posted 13/09/2019
More positive phase III results for rituximab b...Biosimilars/Research | Posted 13/09/2019
Revance Therapeutics focus on its own Botox bio...Biosimilars/News | Posted 13/09/2019
Canadian IBD charity updates biosimilar positio...Biosimilars/General | Posted 13/09/2019

News

Research

General