FDA approval for Amgen’s infliximab biosimilar Avsola

Posted 13/12/2019

US-based biotech giant Amgen announced on 6 December 2019 that it had received approval from the US Food and Drug Administration (FDA) for its inflixima...

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Canadian gastroenterologists issue biosimilar p... Biosimilars/General | Posted 13/12/2019
Bio-Thera gains Chinese approval for adalimumab... Biosimilars/News | Posted 13/12/2019
Bill to stop misuse of Citizen Petitions advanc... Policies & Legislation | Posted 13/12/2019
The impact of generics regulation in Brazil Generics/Research | Posted 13/12/2019
Pharmacists must be ready to take the lead on b... Biosimilars/Research | Posted 13/12/2019
Ontario proposes regulatory changes to simplify... Generics/General | Posted 13/12/2019
Australia approves five biosimilars since June... Biosimilars/News | Posted 06/12/2019
Health Canada publishes biosimilars fact sheet Guidelines | Posted 06/12/2019
Use of pegfilgrastim copy biological Mecapegfil... Biosimilars/Research | Posted 06/12/2019
WHO prequalifies antiparasitic API Generics/General | Posted 06/12/2019
Phase III trials started for bevacizumab and na... Biosimilars/News | Posted 06/12/2019
EMA recommends approval for two new generics Generics/News | Posted 06/12/2019
EC approval for subcutaneous infliximab biosimi... Biosimilars/News | Posted 29/11/2019
WHO launches insulin prequalification programme Biosimilars/General | Posted 29/11/2019
Biosimilar education for Canadian nurses Biosimilars/Research | Posted 29/11/2019
Lupin to launch etanercept and pegfilgrastim b... Biosimilars/News | Posted 29/11/2019
The sluggish US biosimilars market Reports | Posted 29/11/2019
FDA generics approvals increasing but not for a... Generics/Research | Posted 29/11/2019
Concerns raised as Canada’s Alberta plans to sw... Policies & Legislation | Posted 22/11/2019
FDA approves adalimumab biosimilar Abrilada Biosimilars/News | Posted 22/11/2019
Qilu starts phase III trial for denosumab copy... Biosimilars/News | Posted 22/11/2019
Brazilian efficacy and safety data for biosimil... Biosimilars/Research | Posted 22/11/2019
FDA identifies causes of drug shortages, recomm... Generics/General | Posted 22/11/2019
Biologicals and biosimilar use in Asian patient... Biosimilars/Research | Posted 15/11/2019
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
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
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
FDA approves pegfilgrastim biosimilar Ziextenzo Biosimilars/News | Posted 04/11/2019
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
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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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