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US Supreme Court backs FTC in pay-for-delay case Policies & Legislation | Posted 21/06/2013

On 17 June 2013 the US Supreme Court ruled 5-3 in favour of the Federal Trade Commission (FTC) in the case of FTC versus Actavis with respect to reverse patent settlements or ‘pay-for-delay’, as th...

Sandoz comments on EMA’s new draft biosimilars guidance Biosimilars/News | Posted 21/06/2013

Sandoz, the generic drug division of Swiss drug giant Novartis, is pleased that the European Medicines Agency (EMA) has issued a draft revised guideline on non-clinical and clinical issues in biosi...

Biosimilar monoclonal antibodies and pharmacovigilance in Europe Reports | Posted 21/06/2013

EMA Head of Biologicals Dr Peter Richardson and Amgen Director of Value, Access and Policy Mr Thomas Moore speak to BioCentury about biosimilar monoclonal antibodies and pharmacovigilance for biosi...

Actavis submits ANDAs for two more generics Generics/News | Posted 21/06/2013

Actavis has filed for US approval for generic versions of a contraceptive and a sedative/anaesthetic.

EGA pushes for increased focus on generics and biosimilars Conferences | Posted 21/06/2013

EGA President Ms Gudbjorg Edda Eggertsdottir, speaking at the European Generic medicines Association’s (EGA’s) conferences in London, UK (11th EGA International Symposium on Biosimilar Medicines) a...

Revision of guideline on clinical and non-clinical issues for biosimilars Guidelines | Posted 14/06/2013

On 10 June 2013, EMA released a revision of the guideline addressing the clinical and non-clinical issues related to similar biological products (biosimilars) containing biotechnology-derived prote...

Call for clarity in FDA’s draft guidance on biosimilar meetings Biosimilars/General | Posted 14/06/2013

Drug companies have made comments on FDA’s draft guidance for industry on formal meetings between the agency and biosimilars manufacturers. They believe that the guidance needs some revision to pro...

Use of G-CSF biosimilars for reduction of fever Biosimilars/Research | Posted 14/06/2013

The American Society of Hematology, the British Society of Haematology, the European Society of Hematology and the European Group of Bone Marrow Transplantation all recommend the use of granulocyte...