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EMA finalises pharmacovigilance guidance Guidelines | Posted 06/07/2012

EMA announced on 25 June 2012 the release of the finalised versions of seven new guideline modules outlining good pharmacovigilance practices (GVPs) to assist sponsors with complying with the soon-...

India announces free drugs for all―generics only Policies & Legislation | Posted 06/07/2012

In a radical move, the Indian government has pledged to provide free drugs for all from October 2012, with a focus on generic medications as a more affordable option than brand-name drugs. The anno...

Biosimilar infliximab equivalence proven in phase III trial Biosimilars/Research | Posted 06/07/2012

Results from a phase III trial of biosimilar infliximab have proven the equivalence of South Korean biotechnology company Celltrion’s biosimilar (CT-P13) and the reference product – Johnson & J...

UK spending on brand-name drugs predicted to reduce Generics/General | Posted 06/07/2012

Spending by the UK’s National Health Service (NHS) is under control according to a new report, and in fact spending on brand-name medicines is expected to reduce in real terms and as a proportion o...

Generics have their feet under the table in Malaysia Generics/General | Posted 06/07/2012

Generics manufacturing, prescribing and sales are becoming firmly part of the scene in Malaysia.

Copaxone sees off generics challenge Biosimilars/General | Posted 06/07/2012

Teva received a major boost in June 2012, after a US court backed the Israeli firm in a patent dispute concerning its multiple sclerosis blockbuster Copaxone (glatiramer acetate).

Generics companies turn to ‘third tier’ countries Generics/General | Posted 06/07/2012

With pharmaceutical growth in the doldrums in the west, and China and India are becoming increasingly confident, attention is turning to countries such as Indonesia and Turkey.

US$67 billion worth of biosimilar patents expiring before 2020 Biosimilars/General | Posted 29/06/2012

Last updated: 20 January 2014Twelve biological products with global sales of more than US$67 billion will be exposed to biosimilar competition by 2020, with Enbrel (etanercept) whose US patent has...