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Biosimilars/General

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Biosimilars mean competition for biologic brands

Biosimilars/General | Posted 09/04/2010

The historic passage of two US healthcare reform bills on 21 March 2010, including a US Senate bill with an approval pathway for biosimilars, means biologic brands could see rivals replicate and market similar products, writes Mr Marc Iskowitz in Medical Marketing & Media. According to him, the new legislation, signed by US president Mr Barack Obama on 23 March 2010, lays out a series of requirements for the FDA to consider follow-on biologics (FOBs) applications.

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12 years exclusivity workable for patients; not anticompetitive

Biosimilars/General | Posted 26/01/2010

On IPWatchdog.com Gene Quinn distinguishes facts from fiction about biosimilars.

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Will there be unfair delays for the entry of biosimilars?

Biosimilars/General | Posted 15/10/2009

As pointed out by Managing Editor, Ms Maria Fabiana Jorge, in the Editorial of the Journal of Generic Medicines, Volume 6, Issue 4 of August 2009, countries around the world define the future pharmaceutical market, we must learn from the past to avoid making the same mistakes or falling into new ones. Unfortunately, the current system has serious flaws and it seems that we are moving towards creating others in the new one. It is essential that governments, the pharmaceutical industry and civil society throughout the world work closely to strike a better balance between innovation and access in the context of biotechnology medicines.