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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...

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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
Allergan allows Amneal to market Alzheimer’s ge... Generics/News | Posted 23/09/2016
Canadian approval for etanercept biosimilar Biosimilars/News | Posted 16/09/2016
FDA on interchangeability and demonstrating bio... Guidelines | 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
IPRF issues draft reflection paper for biosimil... Guidelines | Posted 09/09/2016
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
EMA adopts new guidance on monitoring of biolog... Guidelines | Posted 02/09/2016
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
EMA reports ‘critical deficiencies’ in Chinese... Pharma News | 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
Fosun Pharma to acquire Gland in largest acquis... Pharma 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
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NON-BIOLOGICAL COMPLEX DRUGS

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

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

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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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