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Biologicals and biosimilar use in Asian patients with IBD

 Posted 15/11/2019

The increasing incidence of inflammatory bowel diseases (IBD) has become a major challenge for gastroenterologists in some Asian countries, particularly Chin...

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Adalimumab copy biological accepted for review... Biosimilars/News | Posted 15/11/2019
Oncology pharmacists issue position statement o... Biosimilars/General | Posted 15/11/2019
Phase I trials started for aflibercept and uste... Biosimilars/News | Posted 15/11/2019
Designing fit-for-purpose biosimilar studies Reports | Posted 15/11/2019
Samsung reveals positive trial results for beva... Biosimilars/Research | Posted 15/11/2019
Safety of generics in US questioned Generics/Research | Posted 15/11/2019
Alvogen gains exclusive rights to market parath... Pharma News | Posted 15/11/2019
Medicines for Europe 18th Biosimilar Medicines... Conferences | Posted 15/11/2019
Terrapinn Festival of Biologics USA 2020 Conferences | Posted 15/11/2019
Medicines for Europe 16th Legal Affairs Confere... Conferences | Posted 15/11/2019
Uptake of biosimilars in different countries va... Reports | Posted 08/11/2019
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FDA approves pegfilgrastim biosimilar Ziextenzo Biosimilars/News | Posted 04/11/2019
EC publishes biosimilar information for healthc... Guidelines | Posted 08/11/2019
Biosimilar regulation in the Middle East Reports | Posted 08/11/2019
Clinical data requirements for biosimilars in t... Biosimilars/Research | Posted 08/11/2019
Generics transition brings economic benefits to... Generics/Research | Posted 08/11/2019
Tanvex BioPharma’s filgrastim biosimilar comes... Biosimilars/News | Posted 08/11/2019
Glenmark and Lupin gain FDA approval for nervou... Generics/News | Posted 08/11/2019
Biosimilars regulation in Canada: state of play Biosimilars/Research | Posted 04/11/2019
Considerations for real-world research on biosi... Reports | Posted 04/11/2019
Clinical data requirements for biosimilars in t... Biosimilars/Research | Posted 04/11/2019
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US Senators reveal plans to lower drug prices Policies & Legislation | Posted 04/11/2019
Biocon acquires Pfizer research facility and si... Pharma News | Posted 04/11/2019
A call for economic reassessment of drug regimens Generics/Research | Posted 04/11/2019
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Bevacizumab ‘similar biologic’ Versavo launched... Biosimilars/News | Posted 04/11/2019
FDA issues final guidance on petitions delaying... Guidelines | Posted 04/11/2019
Pharmacy chain drives choice among US generics... Generics/Research | Posted 25/10/2019
Clinical data requirements for biosimilars in t... Biosimilars/Research | Posted 25/10/2019
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EMA approval for Pegfilgrastim Mundipharma Biosimilars/News | Posted 25/10/2019
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Impact of biologicals on health care Reports | Posted 25/10/2019
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UK Labour Party proposes state run generics man... Generics/General | Posted 25/10/2019
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Positive real-world data for etanercept biosimi... Biosimilars/Research | Posted 25/10/2019
Canada amends its drug pricing regulations Policies & Legislation | Posted 25/10/2019
Lupin to sell Japanese injectables business and... Pharma News | Posted 25/10/2019
Clinical data requirements for biosimilars in t... Biosimilars/Research | Posted 18/10/2019
Russian approval for non-originator dornase alfa Biosimilars/News | Posted 18/10/2019
FDA planning more guidance for developers of co... Guidelines | Posted 18/10/2019
Celltrion and Juno make biosimilars deal in Aus... Biosimilars/General | Posted 18/10/2019
Trial of bevacizumab copy biological with novel... Biosimilars/Research | Posted 18/10/2019
First pregabalin generics approved by FDA Generics/Research | Posted 18/10/2019
Further collaborations formed to penetrate Chin... Pharma News | Posted 18/10/2019
Ranitidine recalls escalate as FDA declares ‘un... Generics/General | Posted 18/10/2019
Medicines for Europe 13th Pharmacovigilance Con... Conferences | Posted 18/10/2019
Medicines for Europe 19th Regulatory and Scient... Conferences | Posted 18/10/2019
Clinical data requirements for biosimilars in t... Biosimilars/Research | Posted 11/10/2019
FDA approves Pfenex’s follow-on teriparatide pr... Biosimilars/News | Posted 11/10/2019
EMA provides guidance on avoiding nitrosamines... Guidelines | Posted 11/10/2019
Biocon/Mylan launch first insulin glargine bios... Biosimilars/News | Posted 11/10/2019
FDA releases new patient guidance on biosimilars Biosimilars/General | Posted 11/10/2019
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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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