News

EMA issues concept paper for revision of immunogenicity guideline

Published on 2014/11/05

On 25 March 2013 the European Medicines Agency (EMA) announced the publication of a concept paper to discuss the revision of the guideline on immunogenicity assessment of biotechnology-derived thera...

37 views

Read more →

Indiana biosimilars substitution bill becomes law

Published on 2014/11/03

Indiana Governor Mike Pence signed into law on 25 March 2014 legislation that will allow pharmacists to substitute biosimilars that the US Federal Drug Administration (FDA) has approved as interchan...

38 views

Read more →

The non-financial benefits of generics substitution

Published on 2014/10/30

Switching between different generic brands of metformin is a good cost-effective approach that does not adversely affect the quality of care for patients with type 2 diabetes, according to the resul...

34 views

Read more →

European doctors have insufficient knowledge of biosimilars

Published on 2014/10/28

The Alliance for Safe Biologic Medicines (ASBM), which represents patients and physicians, as well as originator biological and biosimilar medicines companies in the US, published results of a surve...

31 views

Read more →

Diabetes and high blood pressure generics in Europe

Published on 2014/10/24

Generics contribute value to the European Union (EU), according to a presentation by Mr Victor Lino Mendonça given at the International Generic Pharmaceutical Alliance (IGPA)’s 16th Annual Confer...

62 views

Read more →

Proposal in Brazil to exempt medicines from tax

Published on 2014/10/22

The Brazilian Government announced on 9 February 2014 that it is setting up a committee to evaluate whether to exempt medicines from tax in the country. The joint committee will be set up in order ...

23 views

Read more →

GPhA proposes using manufacturer names to distinguish biosimilars

Published on 2014/10/20

The Generic Pharmaceutical Association (GPhA) has proposed a compromise naming scheme for biosimilars that it hopes will end the dispute over how to assign international non-proprietary names (INNs)...

29 views

Read more →

Are biosimilars worth it?

Published on 2014/10/16

Will off-patent biological medicines offer the same cost savings as those seen with off-patent non-biological (chemically derived) medicines? A group of health economists based in Brussels, Belgium,...

31 views

Read more →

EMA and FDA extend quality collaboration

Published on 2014/10/14

The European Medicines Agency (EMA) announced on 6 March 2014 that as of 1 April 2014 EMA and the US Food and Drug Administration (FDA) have agreed on a two-year extension of their joint pilot progr...

16 views

Read more →

Brand-name drugs also cut healthcare costs

Published on 2014/10/10

Generics are often given all the praise when it comes to cutting costs for patients and payers, but, according to a piece in Forbes, brand-name drugs also cut healthcare costs. Generics, it i...

32 views

Read more →

How safe is Zarzio after five years’ clinical experience?

Published on 2014/10/08

The first filgrastim biosimilar was approved in Europe in 2008, prompting Dr Pere Gascón and co-authors to review the evidence relating to the efficacy and safety of biosimilar Zarzio (filgrastim) ...

28 views

Read more →

Generics contribution to availability of essential medicines

Published on 2014/10/06

The creation of Essential Medicines Lists (EMLs) within country healthcare systems is promoted by the World Health Organization (WHO) in order to improve the availability and use of medicines consid...

14 views

Read more →