Biosimilar User Fee Act reauthorization

Posted 23/09/2016

On 16 September 2016, the US Food and Drug Administration (FDA) released the Biosimilar User Fee Act II (BsUFA II) performance goals letter, attracting suppo...

Different approaches to bioequivalence trials f... Generics/Research | Posted 23/09/2016
FDA approves biosimilar etanercept Erelzi Biosimilars/News | Posted 23/09/2016
Regulation of biosimilars in Japan Reports | Posted 23/09/2016
Why do generic drug prices keep on rising? Generics/General | Posted 23/09/2016
Positive phase III results for Sandoz etanercep... Biosimilars/Research | Posted 23/09/2016
Canadian approval for etanercept biosimilar Biosimilars/News | Posted 16/09/2016
Study supports interchangeability of TNF-α bios... Biosimilars/Research | Posted 16/09/2016
South Africa’s expedited registration policy no... Generics/Research | Posted 16/09/2016
Pfizer antibiotics banned across the EU Pharma News | Posted 16/09/2016
More positive phase I results for Coherus pegfi... Biosimilars/Research | Posted 16/09/2016
Patent wins and losses for Teva Generics/News | Posted 16/09/2016
Generics applications under review by EMA – Aug... Generics/General | Posted 16/09/2016
GPhA 2016 Fall Technical Conference Conferences | Posted 16/09/2016
Mylan and Biocon submit trastuzumab biosimilar... Biosimilars/News | Posted 09/09/2016
Biosimilars for use in fertility treatment Biosimilars/Research | Posted 09/09/2016
Biosimilars applications under review by EMA –... Biosimilars/General | Posted 09/09/2016
South Africa’s expedited registration policy fo... Generics/Research | Posted 09/09/2016
Australia cuts prices of more than 2,000 brand-... Policies & Legislation | Posted 09/09/2016
Safety and efficacy of Remsima in IBD patients... Biosimilars/Research | Posted 09/09/2016
Equivalence of Complex Drug Products: Scientifi... Conferences | Posted 09/09/2016
Use of biosimilars in oncology in France Biosimilars/Research | Posted 02/09/2016
Driving down drug prices: how regulators can in... Generics/Research | Posted 02/09/2016
FDA accepts application for Merck’s follow-on i... Biosimilars/News | Posted 02/09/2016
Indian generics manufacturer Lupin buys 21 bran... Generics/General | Posted 02/09/2016
Senators continue to raise concerns over price... Generics/News | Posted 02/09/2016
FDA lowers fees for generic drug applications Policies & Legislation | Posted 02/09/2016
Pharmaceutical price regulation in Saudi Arabia... Biosimilars/Research | Posted 26/08/2016
Positive phase III results for Amgen’s trastuzu... Biosimilars/Research | Posted 26/08/2016
Generics in seizure control Generics/Research | Posted 26/08/2016
Biosimilars of basiliximab Biosimilars/General | Posted 26/08/2016
Janssen Biotech files lawsuits for infringement... Biosimilars/News | Posted 26/08/2016
Mylan gives up two generic drugs to allow for a... Policies & Legislation | Posted 26/08/2016
New generic versions of imatinib mesylate join... Generics/News | Posted 26/08/2016
BioProduction Congress 2016 Conferences | Posted 26/08/2016
Biosimilars North America Conferences | Posted 26/08/2016
Pharmacovigilance of biologicals in Denmark Biosimilars/Research | Posted 19/08/2016
Biosimilars of omalizumab Biosimilars/General | Posted 19/08/2016
Mylan and Biocon submit pegfilgrastim biosimila... Biosimilars/News | Posted 19/08/2016
EMA halts sales of unreliable generics Generics/General | Posted 19/08/2016
Bevacizumab similar biologics launched in India Biosimilars/News | Posted 19/08/2016
Evolution of biosimilars in developed and devel... Biosimilars/Research | Posted 19/08/2016
Launches, approvals and court cases for Sun Pharma Generics/News | Posted 19/08/2016
Biosimilars: the benefits need to be communicated Biosimilars/Research | Posted 12/08/2016


Cancer lab to evaluate bioequivalence of nanosimilars Posted 23/09/2016

The Frederick National Laboratory for Cancer Research (Frederick National Lab...


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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