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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...

India releases draft ‘similar biologic’ guidelines Guidelines | Posted 29/06/2012

India has released regulatory guidelines outlining a simple abridged procedure for evaluation of ‘similar biologics’ which have been approved and marketed in India, Europe or USA for more than four...

Is the pharmaceutical industry on the verge of as big a change as we have seen? Generics/General | Posted 29/06/2012

‘The old order changeth, yielding place to new’ [1]For many years the Trade Related Intellectual Property Rights (TRIPS) negotiations have been criticised as being overly protective of the rights o...

Phase I trial of biosimilar infliximab proves biosimilarity Biosimilars/Research | Posted 29/06/2012

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

More downs than ups for Ranbaxy Generics/News | Posted 29/06/2012

A further problem with Indian generics manufacturer Ranbaxy Laboratories (Ranbaxy) could affect its reputation yet again with US FDA. This time, Ranbaxy fell foul of an Indian state regulator, the...

Small molecule versus biological drugs Biosimilars/Research | Posted 29/06/2012

Biological drugs are large and complex, often consisting of heterogeneous mixtures. They are generally made in genetically engineered cells that impose their own variabilities–in post-translation m...