FDA issues final guidance on interchangeable biologicals

Posted 17/05/2019

The US Food and Drug Administration (FDA) announced on 10 May 2019 that it had issued final guidance on the pathway for interchangeable biologicals.

more
Canadian organizations collaborate to improve b... Biosimilars/General | Posted 17/05/2019
Multi-state lawsuit alleges widespread generic... Generics/General | Posted 17/05/2019
Adalimumab biosimilar Idacio launched in Germany Biosimilars/News | Posted 17/05/2019
ASCO/ASH give recommendations for biosimilar ESAs Biosimilars/Research | Posted 17/05/2019
SMi 10th Annual Biosimilars and Biologics Confe... Conferences | Posted 17/05/2019
Biosimilars education still needed for US and E... Biosimilars/Research | Posted 10/05/2019
EMA approval for pegfilgrastim biosimilar Grasu... Biosimilars/News | Posted 10/05/2019
Automatic pharmacist substitution of biosimilar... Policies & Legislation | Posted 10/05/2019
Patient and provider views on biosimilars to tr... Biosimilars/General | Posted 10/05/2019
Pharmacokinetic assessment of biosimilar therap... Biosimilars/Research | Posted 10/05/2019
FDA approves etanercept biosimilar Eticovo Biosimilars/News | Posted 03/05/2019
ASCO/ASH update ESA recommendations Biosimilars/Research | Posted 03/05/2019
Mixed beliefs about generics among patients in... Generics/Research | Posted 03/05/2019
Biosimilar comparability assessment Biosimilars/Research | Posted 03/05/2019
Australia’s TGA considering whether to publish... Policies & Legislation | Posted 03/05/2019
Health Canada announces naming convention for b... Policies & Legislation | Posted 26/04/2019
FDA to hold public meeting on access to afforda... Biosimilars/General | Posted 26/04/2019
Belgian companies make biosimilars agreement Pharma News | Posted 26/04/2019
Comparability of biosimilar Ontruzant maintaine... Biosimilars/Research | Posted 26/04/2019
Intas launches trastuzumab similar biologic in... Biosimilars/News | Posted 26/04/2019
Clinical development of a bevacizumab biosimilar Biosimilars/Research | Posted 26/04/2019
US Court rejects Teva’s lawsuit over generic Re... Generics/General | Posted 26/04/2019
Biosimilar drug packaging does not meet EU guid... Biosimilars/Research | Posted 19/04/2019
Rituximab biosimilar Truxima approved in Canada Biosimilars/News | Posted 19/04/2019
Eli Lilly to introduce half-price authorized in... Biosimilars/General | Posted 19/04/2019
Online consultation on biological drug naming i... Policies & Legislation | Posted 19/04/2019
Economic considerations for biosimilars in the US Biosimilars/Research | Posted 19/04/2019
Stada launches generic Exforge following patent... Generics/News | Posted 19/04/2019
WHO releases Q&A on biosimilars evaluation Reports | Posted 12/04/2019
EC approval for adalimumab biosimilar Idacio Biosimilars/News | Posted 12/04/2019
Efficacy and safety of bevacizumab biosimilar A... Biosimilars/Research | Posted 12/04/2019
Key considerations for biosimilars in the US Biosimilars/Research | Posted 12/04/2019
US government advances five bills to increase g... Policies & Legislation | Posted 12/04/2019
Biocad advancing its non-originator biologicals... Biosimilars/General | Posted 12/04/2019
FDA releases statement on generic drug quality Generics/General | Posted 12/04/2019
Committing to Global Health: Balancing Access a... Conferences | Posted 12/04/2019
more

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...

more


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
more