More Articles

Free samples increase use of branded drugs Generics/Research | Posted 25/04/2014

The practice of giving free samples to physicians to give out to their patients increases the use of brand-name drugs, according to research published in JAMA Dermatology [1].

Delaware passes biosimilars substitution law Policies & Legislation | Posted 25/04/2014

Delaware has become the latest US state to pass a law allowing substitution of a biosimilar for an originator biological, but with certain restrictions.

FDA defends generics labelling proposal Generics/General | Posted 25/04/2014

The US Food and Drug Administration’s (FDA) Director of the Center for Drug Evaluation and Research, Dr Janet Woodcock, testified before the Subcommittee on Health, Committee on Energy and Commerce...

UK court invalidates Herceptin patents Pharma News | Posted 25/04/2014

A High Court in the UK has overturned two key patents on Roche’s breast cancer blockbuster Herceptin (trastuzumab).

The generics market in India Reports | Posted 25/04/2014

The profitability of generics companies in India is under pressure, according to a presentation by Mr Alok Sonig [1].

Brazil’s ANVISA approves Cristália for production of ‘follow-on biological products’ Biosimilars/News | Posted 25/04/2014

Brazilian drugmaker Cristália has taken a step closer to its goal of producing ‘follow-on biological products’ domestically after receiving clearance from the country’s drug regulator, the Brazilia...

Regulatory principles for biosimilar monoclonal antibodies Biosimilars/Research | Posted 18/04/2014

It is sometimes argued that there is less clinical evidence for biosimilars. However, Tsiftsoglou and co-authors pointed out that European Medicines Agency (EMA) guidelines for biosimilars are not...

Biosimilars knowledge gap needs addressing Biosimilars/General | Posted 18/04/2014

The European Generic medicines Association (EGA) has called upon national authorities and medical societies to actively engage in reducing the knowledge gap about biosimilars.