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American dermatologists update position statement on biosimilar substitution Biosimilars/General | Posted 16/11/2012

On 3 November 2012, the American Academy of Dermatology (AAD) updated its position statement on generics and biosimilar substitution to reflect its views, in particular on interchangeability* and n...

German court rules Seroquel XR patent invalid Generics/News | Posted 16/11/2012

AstraZeneca has lost another battle to protect its blockbuster anti-psychotic drug Seroquel (quetiapine fumarate) against generics.

Biosimilar policies in Spain Reports | Posted 16/11/2012

Spain is Europe’s fifth largest pharmaceutical market [1], however, in 2009, biosimilars accounted for less than 5% of the total biologicals market [2].

Pharmaceutical trade barriers are falling Policies & Legislation | Posted 16/11/2012

The European Parliament has voted in favour of a trade pact between Israel and the European Union (EU) that will allow easier access to medicines from both markets. The EU is also seeking to reduce...

Positive results from phase III study with biosimilar human insulin Biosimilars/Research | Posted 16/11/2012

One of Asia’s leading biotechnology companies, Biocon, announced on 31 October 2012 positive results from its global phase III study for its recombinant human insulin (Insugen). The study, which wa...

EMA approves first generic imatinib Generics/General | Posted 09/11/2012

EMA’s Committee for Medicinal Products for Human Use (CHMP) announced on 18 October 2012 that the agency had approved a generic version of imatinib.

Overview of clinical research on generics in 2012 Generics/Research | Posted 09/11/2012

Period: January to August 2012 Generic drug alternatives to brand-name prescription medications are becoming increasingly important in the global drug market as governments strive to contain h...

Sandoz starts phase III US trial for biosimilar epoetin alfa Biosimilars/Research | Posted 09/11/2012

Sandoz, the generic drug division of Swiss drug giant Novartis, announced on 25 October 2012 that it had started patient enrolment in a phase III clinical trial in the US for biosimilar epoetin alf...