Regulating the safety of biosimilars

posted 12/09/2014

Clinical safety is critically important during the development of a biosimilar. An overview of the main aspects of safety assessment of biosimilars has been...

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FDA debuts purple book for biologicals and inte... Biosimilars/General | Posted 12/09/2014
Pharma’s future in China and the US Generics/Research | Posted 12/09/2014
European approval for biosimilar insulin Biosimilars/News | Posted 12/09/2014
Generic hepatitis drug to be made available to... Generics/General | Posted 12/09/2014
Teva wins another Symbicort patent challenge Generics/News | Posted 12/09/2014
Patients at risk from UK drug shortages Pharma News | Posted 12/09/2014
Generics group calls for say on ICH standards Guidelines | Posted 12/09/2014
Appropriate generics pricing improves medicines... Generics/Research | Posted 05/09/2014
Adalimumab biosimilar has comparable pharmacoki... Biosimilars/Research | Posted 05/09/2014
FDA accepts applications for three-times-weekly... Generics/News | Posted 05/09/2014
Infliximab biosimilar to be distributed by Mund... Biosimilars/News | Posted 05/09/2014
Generics makers comment on draft ANDA guidance Guidelines | Posted 05/09/2014
US senators call for guidance on biosimilars Biosimilars/General | Posted 05/09/2014
Generics companies sue Reckitt Benckisser over... Generics/News | Posted 05/09/2014
The future of biosimilar use and regulation in... Biosimilars/Research | Posted 29/08/2014
Value of generics overlooked in one country tha... Generics/Research | Posted 29/08/2014
Physicians believe biosimilars should have diff... Biosimilars/General | Posted 29/08/2014
FDA receives application for monoclonal antibod... Biosimilars/News | Posted 29/08/2014
Idaho proposes legislation on biosimilars subst... Policies & Legislation | Posted 29/08/2014
Lawyers look at new price hike for old drug Generics/General | Posted 29/08/2014
US court puts generic Gralise on hold Generics/News | Posted 29/08/2014
Trends in the financial burden of diabetes trea... Generics/Research | Posted 22/08/2014
FDA grants tentative approval for insulin treat... Biosimilars/News | Posted 22/08/2014
ECCO survey highlights lack of confidence in bi... Biosimilars/Research | Posted 22/08/2014
Generics shortages continue to rise in the UK Pharma News | Posted 22/08/2014
Generics manufacturers focus on MS drug Ampyra Generics/News | Posted 22/08/2014
More biosimilars collaborations on the cards Biosimilars/News | Posted 22/08/2014
Ranbaxy’s manufacturing woes benefit big pharma Generics/General | Posted 22/08/2014
WHO proposal offers clarity for biosimilar nome... Biosimilars/General | Posted 14/08/2014
Biosimilar events from 2012 to 2014 Reports | Posted 14/08/2014
Right of appeal provision in CETA Generics/Research | Posted 14/08/2014
Biosimilars in the treatment of chemotherapy-in... Biosimilars/Research | Posted 14/08/2014
Biosimilars of cetuximab Biosimilars/General | Posted 14/08/2014
Generics deals for Mylan, Pfizer and Sun Pharma Pharma News | Posted 14/08/2014
Coherus starts phase III biosimilar etanercept... Biosimilars/News | Posted 14/08/2014
Biosimilars deals coming thick and fast Biosimilars/News | Posted 14/08/2014
Switching and extrapolation of subsequent entry... Biosimilars/Research | Posted 08/08/2014
Biosimilar infliximab receives approval in Japa... Biosimilars/News | Posted 08/08/2014
Servier and generics makers fined for pay-for-d... Policies & Legislation | Posted 08/08/2014
Biosimilar trastuzumab similar to Herceptin in... Biosimilars/Research | Posted 08/08/2014
Recalls call into question metoprolol generics Generics/General | Posted 08/08/2014
Actavis submits generic dalfampridine ANDA Generics/News | Posted 08/08/2014
DIA Biosimilars 2014 Conferences | Posted 08/08/2014
FDA accepts biosimilar filgrastim application Biosimilars/News | Posted 01/08/2014
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