More Articles

Teva and Sun Pharma settle battle over generic Protonix Generics/News | Posted 14/06/2013

Pfizer announced on 12 June 2013 that the pharma giant had reached a settlement with generics manufacturers Teva Pharmaceuticals Industries (Teva) and Sun Pharmaceutical Industries (Sun Pharma) for...

Trials to start for biosimilar infliximab and etanercept Biosimilars/News | Posted 14/06/2013

Pfizer is to start a phase I study for its biosimilar infliximab candidate (PF-06438179) and Samsung Bioepsis has initiated a phase III clinical trial for its biosimilar etanercept (SB4), according...

Nigeria needs to combat fake drugs and ageing facilities Pharma News | Posted 14/06/2013

Nigeria has ageing drug-manufacturing facilities and a problem with imports of fake drugs, according to Mr Olakunle Ekundayo, Group Managing Director, Drugfield Pharmaceuticals.

Indian Government moves closer to complying with EU API rules Policies & Legislation | Posted 14/06/2013

On 23 May 2013, the Indian Government announced that it had issued finalized guidelines for drugmakers to comply with a European Union (EU) directive on standards for import of active pharmaceutica...

EMA’s Richardson talks about biosimilars in Europe Reports | Posted 07/06/2013

Biosimilars have been available in Europe for more than seven years. In the US, however, despite legislation being passed in 2010 to allow for a biosimilars pathway, a biosimilar has yet to be appr...

Positive post-marketing data for biosimilar epoetin Biosimilars/Research | Posted 07/06/2013

Injectable generics specialist, Hospira, presented results from a post-marketing study of the company’s European biosimilar epoetin (Retacrit) on 3 June 2013 at the 48th Annual Meeting of the Ameri...

EU to fine 9 drugmakers over pay-for-delay deals Policies & Legislation | Posted 07/06/2013

The European Commission (EC) is reportedly ready to fine Danish pharmaceutical company Lundbeck and eight generics makers over alleged pay-for-delay deals in Europe.

Celltrion applies for Korean approval of biosimilar trastuzumab Biosimilars/News | Posted 07/06/2013

On 4 June 2013, South Korean biotechnology company Celltrion announced that it had filed for approval of its biosimilar candidate CT-P6 with the Korean Ministry of Food and Drug Safety (MFDS, forme...