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Interchangeability (switching and alternating) of biosimilars Biosimilars/Research | Posted 09/12/2011

The Biologics Price Competition and Innovation (BPCI) Act of 2009 established an abbreviated Biologic License Application (aBLA) pathway for the approval of biosimilars in the US. This act also est...

Quality by design for generics by 2013 Generics/General | Posted 09/12/2011

Quality by design (QbD) is already being implemented by FDA for new drug applications, but now, in an attempt to prepare generics manufacturers for QbD in 2013, FDA is preparing to publish immediat...

EU investigation tackles pay-for-delay Reports | Posted 09/12/2011

When the European Commission (EC) was created, one of the founding principles was that of free trade. There should be no barriers to trade within ‘the common market’ as it was called at the time. T...

The pharmaceutical market in Brazil Generics/General | Posted 09/12/2011

The Brazilian pharmaceutical market is the third largest in the Americas region, after Canada and USA, it ranks first in the Latin American region. Pharmaceutical demand will continue to rise, fuel...

Advocates demand generic version of Abbott’s HIV drug Kaletra Generics/News | Posted 09/12/2011

FDA watchdog Public Citizen, along with public health groups in a dozen countries, has launched a global campaign demanding the authorisation of generics competition for Abbott Laboratories’ HIV dr...

Hospira’s manufacturing troubles may add to drug shortages Pharma News | Posted 09/12/2011

Injectable generics specialist, Hospira, is under scrutiny again regarding drug shortages caused by its continuing lack of compliance with FDA requirements. In fact, one analyst from The Wall Stree...

Indian Transgene sells biosimilar to German TSS Export Biosimilars/News | Posted 09/12/2011

India-based biotech company Transgene Biotek Limited (Transgene) announced on 24 November 2011 the sale of technology for biosimilar recombinant human erythropoietin (rh-EPO) to TSS Export GmbH FZE...

National Psoriasis Foundation declares biosimilar stance Biosimilars/News | Posted 02/12/2011

One of the leading psoriasis patient associations in the US, the National Psoriasis Foundation, has publically declared its stance on biosimilars. In an open letter to FDA, the Foundation issued a...