WHO should finalize its BQ guidance

Posted 14/12/2018

According to authors from the US, the World Health Organization (WHO) should finalize its Biological Qualifier (BQ) guidance. Distinguishable naming will all...

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British diabetologists issues position statemen... Biosimilars/General | Posted 14/12/2018
Biosimilars launched in the US at a significant... Biosimilars/News | Posted 14/12/2018
Five more countries added to EU-US mutual recog... Policies & Legislation | Posted 14/12/2018
Positive results for adalimumab and etanercept... Biosimilars/Research | Posted 14/12/2018
FDA approves drug for cancers with specific bio... Generics/News | Posted 14/12/2018
FDA approves first rituximab biosimilar Truxima Biosimilars/News | Posted 07/12/2018
Boehringer Ingelheim and Sandoz abandon biosimi... Biosimilars/General | Posted 07/12/2018
Positive results for Chinese rituximab and tras... Biosimilars/Research | Posted 07/12/2018
Way cleared in US for Suboxone and Zytiga generics Generics/General | Posted 07/12/2018
Positive phase I results for Fresenius Kabi’s p... Biosimilars/Research | Posted 07/12/2018
Glenmark gains FDA approval for MS and pneumoni... Generics/News | Posted 07/12/2018
EC approval for pegfilgrastim biosimilars Pelme... Biosimilars/News | Posted 30/11/2018
Switching from reference products to biosimilar... Biosimilars/Research | Posted 30/11/2018
Effectiveness of chronic hepatitis C treatment... Generics/Research | Posted 30/11/2018
FDA approves more generics in 2018 than any oth... Generics/General | Posted 30/11/2018
Comparative results for CT-P10 in low-tumour bu... Biosimilars/Research | Posted 30/11/2018
Patient, health and trade groups say USMCA will... Policies & Legislation | Posted 30/11/2018
Access! 2019 AAM Annual Meeting Conferences | Posted 30/11/2018
Safety of originator and biosimilar epoetin alf... Biosimilars/Research | Posted 23/11/2018
Insulin glargine biosimilars launched in UK and... Biosimilars/News | Posted 23/11/2018
FDA strengthens and modernizes inspections for... Policies & Legislation | Posted 23/11/2018
Tanvex BioPharma submits filgrastim biosimilar... Biosimilars/News | Posted 23/11/2018
Positive phase III data for adalimumab biosimil... Biosimilars/Research | Posted 23/11/2018
Apotex having trouble with Competitive Generic... Generics/News | Posted 23/11/2018
Another adalimumab copy biological accepted for... Biosimilars/News | Posted 16/11/2018
Higher generics use results in higher Medicare... Generics/Research | Posted 16/11/2018
Generics companies winning the legal battle in... Generics/News | Posted 16/11/2018
Appeal by Australia’s watchdog against Pfizer r... Policies & Legislation | Posted 16/11/2018
Phase I study suggests similarity of omalizumab... Biosimilars/Research | Posted 16/11/2018
DIA Global Annual Meeting 2019 Conferences | Posted 16/11/2018
Ensuring a stable supply of APIs in Japan Generics/Research | Posted 09/11/2018
FDA approves adalimumab and pegfilgrastim biosi... Biosimilars/News | Posted 09/11/2018
Inflectra may not be less expensive than Remica... Biosimilars/Research | Posted 09/11/2018
Phase III study of biosimilar pegfilgrastim con... Biosimilars/Research | Posted 09/11/2018
Teva sues FDA for changing ‘first applicant’ de... Generics/General | Posted 09/11/2018
Brazil to remove backlog for generics Generics/General | Posted 09/11/2018
New Zealand to fund only biosimilar epoetin alfa Policies & Legislation | Posted 09/11/2018
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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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Generics News Research General

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Biosimilars News Research General

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