News
Merck makes biosimilars deal with Samsung Bioepis
2013-05-29 Pharma Giant Merck announced on 20 February 2013 that it had made a deal to develop and commercialize biosimilars with Samsung Bioepis. Samsung Bioepis is… Read More »
The ethics of biosimilars
2013-05-27 Biosimilars in the EU have to undergo a strictly regulated comparability exercise against the reference medicinal product on the physicochemical, analytical, functional, non-clinical and clinical… Read More »
Amgen’s response to biosimilar substitution legislation in US
2013-05-24 Amgen, in a statement issued on 1 February 2013, has hit back at accusations that the biotech giant is attempting to limit the uptake of… Read More »
Assessment of interchangeability under the BPCI Act
2013-05-22 The Biologics Price Competition and Innovation (BPCI) Act gives FDA the authority to designate a biosimilar as interchangeable with its reference product. This means that… Read More »
Biologicals in EU to be identified by brand names
2013-05-20 The European Commission has issued a directive which requires biological products to be identified by brand name and not by international nonproprietary name (INN). The… Read More »
MEPs adopt directive to give quicker access to generics
2013-05-17 Members of the European Parliament (MEPs) have adopted the text of the Transparency Directive 2012/0035(COD) by a large majority in a plenary session of the… Read More »
Biosimilars to replace 70% of chemical drugs
2013-05-15 Biosimilars will replace some 70% of global chemical drugs over the next couple of decades, according to industry experts. This replacement will occur due to… Read More »
Inequality in Europe over access to biologicals for arthritis
2013-05-13 Data from a study presented at the European League Against Rheumatism’s Annual European Congress of Rheumatology, EULAR Congress 2012, demonstrates the vast inequalities in access… Read More »
Generics policies in Europe have room for improvement
2013-05-10 In Europe, generics policies have not yet been implemented to their full extent, according to authors Vogler and Zimmerman, reporting on the 2011 Pharmaceutical Pricing… Read More »
Medicines spending in Brazil
2013-05-08 The Brazilian pharmaceutical market is the third largest in the Americas region, behind the US and Canada; it ranks first in the Latin American region.… Read More »
