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Generics of ADHD drug launched in US Generics/News | Posted 26/06/2015

Shire Pharmaceutical’s (Shire’s) blockbuster attention deficit hyperactivity disorder (ADHD) drug Intuniv is now facing competition as four generics of the therapy have been launched on the US market.

FDA outlines details of surveys into physical differences in generics Guidelines | Posted 26/06/2015

The US Food and Drug Administration (FDA) in a Federal Register notice published on 14 May 2015 has outlined how it will carry out pharmacist and patient surveys into how changes in the physical ch...

Acquisitions for Endo and Strides Pharma News | Posted 26/06/2015

Endo Pharmaceuticals (Endo) and Strides Arcolab (Strides) are both looking at acquisitions as a way to expand their generics businesses.

Biosimilars in the US Biosimilars/Research | Posted 19/06/2015

The US Food and Drug Administration (FDA) approved the country’s first biosimilar Zarxio (filgrastim-sndz) on 6 March 2015 [1]. But how will biosimilars be classified in the future and how will sav...

Australia’s PBAC recommends substitution of biosimilars Biosimilars/General | Posted 19/06/2015

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that biosimilars are suitable for substitution at the pharmacy level.

Colombian guidelines for productos bioterapéuticos similares Guidelines | Posted 19/06/2015

Last update: 26 June 2015The regulatory body for approval of medicines in Colombia is INVIMA – Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Colombia’s National Institute of Food an...

Biosimilars substitution bills become law in four US states Policies & Legislation | Posted 19/06/2015

The latest states to enact laws that allow the substitution of biosimilars at the pharmacy level include Georgia, North Carolina, Tennessee and Washington.

Biosimilar events from 2013 to 2015 Reports | Posted 19/06/2015

During the period of 2013 to 2015, biosimilars has been increasingly on the agenda around the world.  Biosimilars are making steady progress, as can be seen by the increasing number of events,...