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Switching approaches to biosimilars in Nordic countries Reports | Posted 27/10/2017

In the European Union (EU), decisions on the interchangeability or substitution of biosimilars and originator biologicals are not made by the European Medicines Agency (EMA), but at the national le...

European perspective on biosimilars Biosimilars/Research | Posted 27/10/2017

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. The first biosimilar Omnitrope (somatropin) was approved in 2006 [1].

FDA launches educational campaign for biosimilars Biosimilars/General | Posted 27/10/2017

In light of the increasing number of biosimilars becoming available in the US, the US Food and Drug Administration (FDA) announced on 23 October 2017 the launch of its education campaign for biosim...

New guidelines expected to encourage generics in China Guidelines | Posted 27/10/2017

New guidelines have been finalized in China to try and make the country a more drug-friendly market, while also promising progress in the use of generics.

Anti-drug antibody assays for biosimilars and originator biologicals Biosimilars/Research | Posted 27/10/2017

Biosimilar drug development has brought new challenges to bioanalytical ligand-binding assays used to determine drug concentration, anti-drug antibodies and neutralizing antibodies.

Perceptions of generic drugs in Latin America: a Guatemalan case study Generics/Research | Posted 27/10/2017

A recent assessment of generic drug use in Guatemala [1] revealed a widespread lack of trust in generics, due to a combination of poor quality, powerful advertising campaigns and limited state regu...

Novo Nordisk petitions FDA to require clinical trials for Victoza biosimilars Biosimilars/News | Posted 27/10/2017

Danish pharmaceutical company Novo Nordisk has asked the US Food and Drug Administration (FDA) to require clinical trials for biosimilar applications for its blockbuster diabetes drug Victoza (lira...

Lupin launches generic pain-relief med in US Generics/News | Posted 27/10/2017

India-based generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 10 October 2017 that it had launched a generic version of Allergan’s Norco (hydrocodone/acetaminophen) pain medication.