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...

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
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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


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