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EMA rejects comparators from outside EEA for insulin biosimilars Guidelines | Posted 17/04/2015

The European Medicines Agency (EMA) released its finalized guideline on the non-clinical and clinical development of insulin biosimilars in March 2015 [1]. However, while the guidance took into acc...

More US state legislation on biosimilars substitution Policies & Legislation | Posted 17/04/2015

The US Food and Drug Administration (FDA) gave marketing authorization to its first biosimilar in March 2015 [1]. In anticipation of such an approval, many US states are considering, or have introd...

Safety and cost considerations of generic and originator gabapentin Generics/Research | Posted 17/04/2015

The launch of generic garbapentin prompted researchers from the Chulalongkorn University and the King Chulalongkorn Memorial Hospital in Bangkok, Thailand, to carry out a study to compare the safet...

Substitution of biosimilars in the US Biosimilars/Research | Posted 17/04/2015

The approval of the first biosimilar in the US, Zarxio (filgrastim), on 6 March 2015 [1], prompted Sarpatwari and co-authors to investigate how biosimilars might be substituted for originator biolo...

IDT Australia gets FDA nod for 23 generics Generics/News | Posted 17/04/2015

IDT Australia announced on 13 April 2015 that the US Food and Drug Administration (FDA) had accepted the transfer of ownership of 23 generics to the Australia-based company.

Merck outlines biosimilars programme Biosimilars/News | Posted 17/04/2015

During the 35th Annual Health Care Conference held on 2−4 March 2015 in Boston, USA, US pharma giant Merck outlined its biosimilars programme.

Dutch medicines agency says biosimilars ‘have no relevant differences’ to originators Biosimilars/General | Posted 10/04/2015

The Dutch Medicines Evaluation Board (MEB) has updated its position on biosimilars, stating that ‘biosimilars have been proven to have no relevant differences compared to an innovator biological me...

Substitution of generics in the US Biosimilars/Research | Posted 10/04/2015

In order to evaluate how strategies to promote the prescribing of generics by physicians in the US might apply to biosimilars, Sarpatwari and co-authors discuss the types of substitution possible w...