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Also noted on generics: 16 March 2012 Generics/General | Posted 16/03/2012

Prescription drugs to be directly dispensed by pharmacistsFDA has announced a meeting to be held on 22 and 23 March 2012 to discuss the possibility of allowing some prescription drugs to be dispen...

Data publication may address generics misperceptions Generics/Research | Posted 09/03/2012

Wider publication of bioequivalence, safety, or efficacy data to demonstrate the effectiveness of generic drug compounds may help to nullify the last remaining anti-generics argument: that generics...

South Korean guidelines for biosimilars Guidelines | Posted 09/03/2012

Last update:  31 January 2014 The regulatory body for approval of medicines in South Korea is the Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administr...

European biosimilars market to reach almost US$4 billion by 2017 Biosimilars/News | Posted 09/03/2012

According to researchers at Frost & Sullivan, the European market for biosimilars will experience strong growth in the coming years due to patent expiries of blockbuster biologicals between 201...

Generics saved Germany more than 25% in 2011 Generics/General | Posted 09/03/2012

The increased use of generics in Germany has brought about record savings of more than 25% in 2011 compared with 2010. The increased savings have been attributed to the success of measures put in p...

Comparability studies and substitution of biosimilars Biosimilars/Research | Posted 09/03/2012

In order to demonstrate similarity between the biosimilar and the biological reference product, both products must be compared to satisfy quality, safety and efficacy requirements [1].

Biosimilar alliance between Celerion and Ricerca Biosimilars/News | Posted 09/03/2012

Contract research organisations (CROs) Celerion and Ricerca Biosciences announced on 29 February 2012 the formation of an integrated service solution for the development of biosimilar products.

Savings to be made from generics use in Australia Generics/General | Posted 09/03/2012

Increasing the use of generic drugs in Australia could generate ‘hundreds of millions of dollars in savings’ for Australia’s Pharmaceutical Benefits Scheme (PBS) in 2012 [1], ‘eliminating the need...