FDA proposes update to biosimilar naming guideline

Posted 22/03/2019

The US Food and Drug Administration (FDA) has issued a new draft guidance document concerning non-proprietary name suffixes for biological products.

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FDA approves trastuzumab biosimilar Trazimera Biosimilars/News | Posted 22/03/2019
Clinician biosimilar prescribing habits and nee... Biosimilars/Research | Posted 22/03/2019
Factors associated with increased side effects... Generics/Research | Posted 22/03/2019
Celltrion wins biosimilar deals and Duopharma i... Biosimilars/General | Posted 22/03/2019
Comparison of Brazilian regulations for follow-... Biosimilars/Research | Posted 15/03/2019
China approves rituximab copy biological Biosimilars/News | Posted 15/03/2019
UK’s NICE recommends pertuzumab with biosimilar... Biosimilars/News | Posted 15/03/2019
Copy biologicals approved in China Biosimilars/General | Posted 15/03/2019
Trastuzumab biosimilar PF 05280014 non-inferior... Biosimilars/Research | Posted 15/03/2019
New safety requirements for EU medicines Policies & Legislation | Posted 15/03/2019
Escalating prices of generic drugs in the US Generics/Research | Posted 15/03/2019
Impact of proposed changes to FDA approach to b... Biosimilars/Research | Posted 08/03/2019
EC approval for bevacizumab biosimilar Zirabev Biosimilars/News | Posted 08/03/2019
Two more countries added to EU-US mutual recogn... Policies & Legislation | Posted 08/03/2019
Positive phase I results for Mycenax’s tocilizu... Biosimilars/Research | Posted 08/03/2019
Pilot procurement scheme in China cuts drug prices Generics/General | Posted 08/03/2019
Green Shield Canada’s biosimilar switch pilot a... Biosimilars/General | Posted 08/03/2019
Mandatory and non-mandatory switching for biosi... Biosimilars/Research | Posted 01/03/2019
Monoclonal antibody copy biologicals accepted f... Biosimilars/News | Posted 01/03/2019
Positive phase III results for rituximab biosim... Biosimilars/Research | Posted 01/03/2019
The 700-dollar vitamin: excessive generics pric... Generics/Research | Posted 01/03/2019
Australia plans reform of its generics authoriz... Policies & Legislation | Posted 01/03/2019
Pfizer drops five preclinical biosimilar progra... Biosimilars/General | Posted 01/03/2019
USP action plan for generics and FDA new innova... Generics/General | Posted 01/03/2019
Mylan launches Advair generic at 70% discount Generics/News | Posted 01/03/2019
Questions over DANBIO relevance for non-medical... Biosimilars/Research | Posted 22/02/2019
EC approval for pegfilgrastim biosimilar Fulphila Biosimilars/News | Posted 22/02/2019
UK pharmacists gain powers to address drug shor... Policies & Legislation | Posted 22/02/2019
Biosimilar teriparatide approved for the treatm... Biosimilars/Research | Posted 22/02/2019
Sandoz makes biological deal in China Pharma News | Posted 22/02/2019
Three FDA approvals for Glenmark as it enters U... Biosimilars/News | Posted 22/02/2019
Safety surveillance of bevacizumab biosimilar (... Generics/Research | Posted 15/02/2019
PanGen gains Malaysian approval for epoetin alf... Biosimilars/News | Posted 15/02/2019
European regulatory framework for approval of b... Generics/Research | Posted 15/02/2019
45 US states have passed biosimilar substitutio... Policies & Legislation | Posted 15/02/2019
Impact of generic reference pricing on candesar... Generics/Research | Posted 15/02/2019
Zydus gets FDA approval for skin, heart and aci... Generics/News | Posted 15/02/2019
Long-term stability of trastuzumab biosimilar u... Biosimilars/Research | Posted 08/02/2019
EMA approval for adalimumab biosimilars Idacio... Biosimilars/News | Posted 08/02/2019
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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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