FDA issues final guidance on biosimilar user fees

Posted 20/07/2018

The US Food and Drug Administration (FDA) has issued final guidance on the agency’s Biosimilar User Fee Act (BsUFA) II fee structure finalizing the changes i...

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Positive phase III results for Amgen’s inflixim... Biosimilars/Research | Posted 20/07/2018
Patient sociodemographics and use of generics Generics/Research | Posted 20/07/2018
Russian court approves first compulsory licence Policies & Legislation | Posted 20/07/2018
MSF challenges hepatitis C patent in China Generics/General | Posted 20/07/2018
Rituximab biosimilar submitted to EMA and Ritux... Biosimilars/News | Posted 20/07/2018
Generic cancer pain relief launched in Japan Generics/News | Posted 20/07/2018
Biosimilars: implications for oncologists Biosimilars/Research | Posted 13/07/2018
Pfizer gains Japanese approval for infliximab b... Biosimilars/News | Posted 13/07/2018
Generic sofosbuvir and daclatasvir bioequivalen... Generics/Research | Posted 13/07/2018
Hatch aims to promote biosimilars and generics... Policies & Legislation | Posted 13/07/2018
Positive results for infliximab and trastuzumab... Biosimilars/Research | Posted 13/07/2018
US pharmacies sue J&J for stifling inflixim... Biosimilars/General | Posted 13/07/2018
FDA approves first Suboxone generics for opioid... Generics/News | Posted 13/07/2018
FDA withdraws biosimilar statistical guidance Guidelines | Posted 06/07/2018
Biosimilars applications under review by EMA –... Biosimilars/General | Posted 06/07/2018
Biosimilarity testing using very low doses of r... Biosimilars/Research | Posted 06/07/2018
FDA rejects botulinum toxin biosimilar from Evolus Biosimilars/News | Posted 06/07/2018
Analytical similarity for biosimilars Reports | Posted 06/07/2018
China to extend drug patents and tackle anticom... Policies & Legislation | Posted 06/07/2018
UK investigates price increases for generics Generics/General | Posted 06/07/2018
Medicines for Europe 2nd Value Added Medicines... Conferences | Posted 06/07/2018
SMi 5th Annual Biosimilars USA Conference 2018 Conferences | Posted 06/07/2018
Biosimilars development moving to Asia Reports | Posted 29/06/2018
FDA rejects Amgen’s trastuzumab biosimilar Biosimilars/News | Posted 29/06/2018
Biosimilar insulins have same efficacy and safe... Biosimilars/Research | Posted 29/06/2018
Biosimilar infliximab blocked in Australia Biosimilars/General | Posted 29/06/2018
Savings with use of biosimilar trastuzumab for... Biosimilars/Research | Posted 29/06/2018
Generic clopidogrel non-inferior to Plavix in a... Generics/Research | Posted 29/06/2018
DIA Biosimilars Conference 2018 Conferences | Posted 29/06/2018
Terrapinn World Biosimilar Congress 2018 Conferences | Posted 29/06/2018
Biosimilars and the role of regulatory authorities Biosimilars/Research | Posted 22/06/2018
Celltrion resubmits biosimilar trastuzumab to FDA Biosimilars/News | Posted 22/06/2018
Developing biosimilars Reports | Posted 22/06/2018
Efficacy, safety and immunogenicity of adalimum... Biosimilars/Research | Posted 22/06/2018
FDA publishes list of companies that block gene... Generics/General | Posted 22/06/2018
US approval for prostate cancer formulation and... Generics/News | Posted 22/06/2018
Spanish associations sign biosimilars collabora... Biosimilars/General | Posted 22/06/2018
Life cycle and regulatory evaluation of biosimi... Biosimilars/Research | Posted 15/06/2018
Etanercept biosimilars submitted to EMA and lau... Biosimilars/News | Posted 15/06/2018
EC proposes waiver of SPCs to allow manufacturi... Policies & Legislation | Posted 15/06/2018
Doctors’ perceptions of generics in Guadeloupe... Generics/Research | Posted 15/06/2018
WuXi Biologics expands its biologicals manufact... Biosimilars/General | Posted 15/06/2018
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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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