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...

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


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

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