Biosimilar drug packaging does not meet EU guidelines on readability

Posted 19/04/2019

Analysis of 35 biosimilar medicines licensed by the European Medicines Agency (EMA) finds packaging to be more complex than recommended. None of the packagin...

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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
ESMO survey highlights need for education and a... Biosimilars/Research | Posted 05/04/2019
Sandoz resubmits pegfilgrastim biosimilar to FDA Biosimilars/News | Posted 05/04/2019
Phase III clinical trials started for adalimuma... Biosimilars/Research | Posted 05/04/2019
Samsung Bioepis invalidates Herceptin patent in... Biosimilars/General | Posted 05/04/2019
Biosimilars of pertuzumab Biosimilars/General | Posted 05/04/2019
Spotlight on the role of pharmacy benefit manag... Generics/General | Posted 05/04/2019
IQPC Biosimilar Commercialisation Summit 2019 Conferences | Posted 05/04/2019
How can EU policymakers access the potential of... Biosimilars/Research | Posted 01/04/2019
Japanese approval for Lupin’s etanercept biosim... Biosimilars/News | Posted 01/04/2019
Use of biosimilars in oncology in Europe Reports | Posted 01/04/2019
Comparison of autoinjectors for inflammatory jo... Biosimilars/Research | Posted 01/04/2019
Biosimilars of somatropin Biosimilars/General | Posted 01/04/2019
Market evolution of new drug formulations Generics/Research | Posted 01/04/2019
Bio-Thera advances bevacizumab and tocilizumab... Biosimilars/News | Posted 01/04/2019
Anti-price gouging: legislation introduced in S... Policies & Legislation | Posted 01/04/2019
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
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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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