EMA accepts application for ranibizumab biosimilar from Samsung Bioepis

Posted 23/10/2020

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 6 October 2020 that the European Medicines Agency (EMA) has accepted to review...

Biosimilar assessments: do we need efficacy tri... Biosimilars/Research | Posted 23/10/2020
Biopharmaceuticals and biosimilars: manufacturi... Biosimilars/Research | Posted 23/10/2020
China’s draft measures for patent linkage system Policies & Legislation | Posted 23/10/2020
Reforms to health policy needed in Europe Generics/General | Posted 23/10/2020
Medicare Part D favours generics over brand-nam... Generics/Research | Posted 23/10/2020
Biopharmaceuticals and biosimilars: manufacturi... Biosimilars/Research | Posted 16/10/2020
EC approval for bevacizumab biosimilar Equidacent Biosimilars/News | Posted 16/10/2020
China accepts application for bevacizumab copy... Biosimilars/News | Posted 16/10/2020
Pharmacists are key to quality use of medicines... Biosimilars/Research | Posted 16/10/2020
Sun Pharma launches Ilumya in Japan and favipir... Generics/News | Posted 16/10/2020
Australian diabetes organizations issue biosimi... Biosimilars/General | Posted 16/10/2020
Clinical review of biosimilars approved in onco... Biosimilars/Research | Posted 09/10/2020
Biopharmaceuticals and biosimilars: challenges... Biosimilars/Research | Posted 09/10/2020
China approves adalimumab copy biological Sulinno Biosimilars/News | Posted 09/10/2020
The landscape for orphan drugs in Europe Reports | Posted 09/10/2020
Structural reforms are required to make Japan’s... Generics/General | Posted 09/10/2020
Mylan/Synthon win European patent ruling on gen... Policies & Legislation | Posted 09/10/2020
Why biosimilar applications fail during regulat... Biosimilars/Research | Posted 02/10/2020
Spectroscopy remains dominant when investigatin... Biosimilars/Research | Posted 02/10/2020
Cadila launches two new similar biologics in India Biosimilars/News | Posted 02/10/2020
Biocon and Celltrion make progress in the battl... Biosimilars/News | Posted 02/10/2020
Sustainable market scorecard represents gold-st... Biosimilars/General | Posted 02/10/2020
Out-of-pocket spending caps cut patient spendin... Generics/Research | Posted 02/10/2020
Phase III trial updates of Samsung Bioepis’ bev... Biosimilars/Research | Posted 25/09/2020
Indications expanded for Merck’s etanercept bio... Biosimilars/News | Posted 25/09/2020
FDA to investigate PD biomarkers to show biosim... Biosimilars/Research | Posted 25/09/2020
FDA invites comments on research into disclosur... Policies & Legislation | Posted 25/09/2020
FDA updates Purple Book database Biosimilars/General | Posted 25/09/2020
EMA recommends approval for arsenic trioxide an... Generics/News | Posted 25/09/2020
Insulin glargine biosimilar Semglee launched in US Biosimilars/News | Posted 18/09/2020
Biosimilars allow fast access to biological dru... Biosimilars/Research | Posted 18/09/2020
Brazil publishes pathway for accelerating innov... Policies & Legislation | Posted 18/09/2020
What oncologists do not understand about biosim... Biosimilars/Research | Posted 18/09/2020
The benefits of tracking generic drug quality Generics/General | Posted 18/09/2020
Country scorecards show biosimilar sustainability Biosimilars/General | Posted 18/09/2020
Inter partes review and the generic drug industry Policies & Legislation | Posted 18/09/2020
Budget savings from biosimilar infliximab in th... Biosimilars/Research | Posted 11/09/2020
Samsung Bioepis launches Ontruzant in Brazil Biosimilars/News | Posted 11/09/2020


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