FDA issues draft guidance on licensing biosimilars for fewer indications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The US Food and Drug Administration (FDA) announced in February 2020 that it had issued draft guidance on getting approval for biosimilars for just some of t...

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


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