FDA issues draft guidance on licensing biosimilars for fewer indications

Posted 14/02/2020

The US Food and Drug Administration (FDA) announced in February 2020 that it had issued draft guidance on getting approval for biosimilars for just some of t...

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Pfizer launching biosimilars in US and Japan bu... Biosimilars/News | Posted 14/02/2020
Relative bioavailability of FKB327 when adminis... Biosimilars/Research | Posted 14/02/2020
Phase III trial started in China for eculizumab... Biosimilars/News | Posted 14/02/2020
Achieving fairer prices for generics and biosim... Biosimilars/Research | Posted 14/02/2020
Irish pharmaceutical association urges politica... Generics/General | Posted 14/02/2020
European Court of Justice backs UK in pay-for-d... Policies & Legislation | Posted 14/02/2020
Key issues for adalimumab biosimilars Biosimilars/Research | Posted 07/02/2020
EMA approval for rituximab biosimilar Ruxience Biosimilars/News | Posted 07/02/2020
Failures when switching patients to biosimilar... Biosimilars/Research | Posted 07/02/2020
Rituximab biosimilar ABP 798 submitted to FDA Biosimilars/News | Posted 07/02/2020
New pricing system for drugs in Russia Policies & Legislation | Posted 07/02/2020
Japanese opportunity for biosimilars Reports | Posted 07/02/2020
Generics applications under review by EMA – Jan... Generics/General | Posted 07/02/2020
AAM Annual Meeting – Access! 2020 Conferences | Posted 07/02/2020
Top 10 most read GaBI Online articles in 2019 Pharma News | Posted 31/01/2020
Law and ethics of switching to biosimilars in C... Biosimilars/Research | Posted 31/01/2020
Biosimilars applications under review by EMA –... Biosimilars/General | Posted 31/01/2020
Mabpharm files infliximab copy biological appli... Biosimilars/News | Posted 31/01/2020
Adalimumab biosimilars in Europe: a review Biosimilars/Research | Posted 31/01/2020
Chemically synthesized polypeptides to use bios... Policies & Legislation | Posted 31/01/2020
China approves bevacizumab copy biological Ankada Biosimilars/News | Posted 31/01/2020
FDA approves generics for cancer and gout Generics/News | Posted 31/01/2020
DIA 2020 Global Annual Meeting Conferences | Posted 31/01/2020
Swiss position statement on the use of biosimil... Biosimilars/Research | Posted 24/01/2020
Teriparatide biosimilar Terossa approved in Sou... Biosimilars/News | Posted 24/01/2020
Eli Lilly and Novo Nordisk launches lower-price... Biosimilars/General | Posted 24/01/2020
FDA sets up centre to improve quality of compou... Generics/General | Posted 24/01/2020
Bevacizumab and teriparatide biosimilars launch... Biosimilars/News | Posted 24/01/2020
Real-life clinical effectiveness of Razumab in... Biosimilars/Research | Posted 24/01/2020
US government department proposes rule to lower... Policies & Legislation | Posted 24/01/2020
WHO prequalifies first biosimilar Biosimilars/General | Posted 17/01/2020
US and EU sign milestone mutual recognition agr... Policies & Legislation | Posted 17/01/2020
Samsung Bioepis and AffaMed to start trastuzuma... Biosimilars/News | Posted 17/01/2020
Biocad announces positive rituximab results and... Biosimilars/Research | Posted 17/01/2020
Medicare Part D has no impact on generics presc... Generics/Research | Posted 17/01/2020
Positive trial results for Lannett’s insulin bi... Biosimilars/Research | Posted 17/01/2020
FDA approves MS and prostate generics Generics/News | Posted 17/01/2020
NeuClone progress with ustekinumab and trastuzu... Biosimilars/Research | Posted 10/01/2020
Non-originator biologicals approved in Russia Biosimilars/General | Posted 10/01/2020
American College of Physicians makes new recomm... Generics/Research | Posted 10/01/2020
Analytical similarity assessment of teriparatid... Biosimilars/Research | Posted 10/01/2020
UnitedHealthcare sues generics manufacturers fo... Policies & Legislation | Posted 10/01/2020
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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...

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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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