FDA issues draft guidance on biosimilar interchangeability

Posted 20/01/2017

The US Food and Drug Administration (FDA) has finally issued its much anticipated guidance on the interchangeability of biosimilars with their reference biol...

European oncologists back biosimilars with posi... Biosimilars/General | Posted 20/01/2017
Generics applications under review by EMA – Dec... Generics/General | Posted 20/01/2017
EMA approval for rituximab biosimilar Truxima Biosimilars/News | Posted 20/01/2017
Natco Pharma and Alvogen launch first US Tamifl... Generics/News | Posted 20/01/2017
What internists should know about biologicals a... Biosimilars/Research | Posted 20/01/2017
EDQM 2017 events Conferences | Posted 20/01/2017
SMi 9th Adaptive Designs in Clinical Trials 2017 Conferences | Posted 20/01/2017
Benepali gains approval for extra indications Biosimilars/News | Posted 13/01/2017
UK competition authority accuses Actavis of ove... Generics/General | Posted 13/01/2017
Biosimilars applications under review by EMA –... Biosimilars/General | Posted 13/01/2017
Colombia slashes price of cancer treatment Glivec Policies & Legislation | Posted 13/01/2017
Positive phase III results for adalimumab and t... Biosimilars/Research | Posted 13/01/2017
Mylan launches generic EpiPen Generics/News | Posted 13/01/2017
Top 10 most read GaBI Online articles in 2016 Pharma News | Posted 06/01/2017
Naming affects pharmacists’ perceptions and dis... Biosimilars/Research | Posted 06/01/2017
EMA accepts application for pegfilgrastim biosi... Biosimilars/News | Posted 06/01/2017
Competition does not curb high drug prices Generics/General | Posted 06/01/2017
Positive phase III results for Boehringer’s ada... Biosimilars/Research | Posted 06/01/2017
Lupin and Natco’s Armodafinil generic approved... Generics/News | Posted 06/01/2017
Bevacizumab biosimilar application submitted to... Biosimilars/News | Posted 09/12/2016
Demonstrating biosimilarity in the EU Reports | Posted 09/12/2016
Positive phase III results for Celltrion’s ritu... Biosimilars/Research | Posted 09/12/2016
Mylan and Biocon submit trastuzumab biosimilar... Biosimilars/News | Posted 09/12/2016
Japan joins international GMP collaboration Policies & Legislation | Posted 09/12/2016
Positive results for etanercept and bevacizumab... Biosimilars/Research | Posted 09/12/2016
Sun Pharma to acquire Russia’s Biosintez Pharma News | Posted 09/12/2016
Addressing patient misconceptions about generics Generics/Research | Posted 02/12/2016
Biosimilar rituximab approved in South Korea Biosimilars/News | Posted 02/12/2016
Biosimilars of abatacept Biosimilars/General | Posted 02/12/2016
Mylan and Biocon submit insulin glargine biosim... Biosimilars/News | Posted 02/12/2016
Biosimilars help reduce the costs of cancer care Biosimilars/Research | Posted 02/12/2016
FDA reports record number of generics approvals Generics/General | Posted 02/12/2016
Mylan to make generic hepatitis drug under MPP... Generics/News | Posted 02/12/2016
13th Legal Affairs Conference Conferences | Posted 02/12/2016
15th Biosimilar Medicines Conference Conferences | Posted 02/12/2016
Safety differences in clinical trials for biosi... Biosimilars/Research | Posted 25/11/2016
FDA accepts application for bevacizumab biosimilar Biosimilars/News | Posted 25/11/2016
Assessing analytical comparability for G-CSF bi... Biosimilars/Research | Posted 25/11/2016
FDA amends citizen petition rules to reduce del... Policies & Legislation | Posted 25/11/2016
Policies to address price rises in old generics Generics/Research | Posted 25/11/2016
Portuguese dermatologists’ position on the use... Biosimilars/General | Posted 25/11/2016


In vitro analysis of follow-on versions of sevelamer Posted 18/11/2016

Authors from the US Food and Drug Administration (FDA) have published details...


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