Twelve-year biologicals exclusivity challenged

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US Californian Democrat Mr Henry Waxman at the World Generic Medicines Congress Americas 2010 challenged the 12-year exclusivity period for originator biologicals.


Healthcare reform in the US has been brought into force by the Patient Protection and Affordable Care Act (amended by the Health Care and Education Reconciliation Act) and was signed into law on 23 March 2010 by President Barack Obama.

This reform also allows for a pathway for marketing approval of biosimilar medicines, after a period of 12 years of exclusivity for the originator biological.

The 12-year exclusivity period granted to manufacturers of branded biologicals in healthcare overhaul legislation was a much-discussed topic at the World Generic Medicines Congress Americas 2010 held on 16–19 November 2010 in Washington DC, USA. The exclusivity period has faced fierce opposition from both generic manufacturers and politicians, such as Mr Henry Waxman, who vowed to continue to fight to reduce the period of exclusivity to something more akin to the five years that apply to conventional chemical or small-molecule drugs.

The congressman said that the legislation as written would not help lower the cost of biologicals and he would fight to have it changed. He added that “the legislation did not balance appropriately the incentives for innovation with the incentives for competition” and that “this was clearly an opportunity lost”.

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US healthcare reform

Source: FDAnews

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