Exclusivity for biological drugs in the US: what now

Home/Policies & Legislation | Posted 25/02/2011 post-comment0 Post your comment

Drugmakers have been embroiled in an epic battle over the length of the exclusivity period that biological drugs can enjoy before generic competition. Everyone from legislators to senators to health insurers—and of course both branded and generic manufacturers—has ‘weighed in’ on the debate.


The issue has major ramifications for different players in the healthcare industry and now it seems the goalposts have been moved once again with President Barack Obama announcing, in his 2012 budget, a change from 12 to seven years exclusivity for biologicals.

The biosimilars pathway

Healthcare reform in the US was 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 Obama.

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

The debate

The bill, however, does not define exactly what ‘exclusivity’ means. Is it ‘market exclusivity’, which would allow generic drugmakers to launch 12 years and one day after the original approval, provided the patents were already expired? Or is it ‘data exclusivity’, which would delay entrance considerably, denying generic drugmakers access to the data until 12 years have elapsed.

The 2012 budget

President Obama has now issued rules to boost competition in the biotech drug market as part of his 2012 budget proposal.

Amongst these measures to boost competition, brand-name drug manufacturers will now be allowed seven years of market exclusivity before biosimilars can be sold in the US, instead of 12 years, as originally proposed.

It is still not clear, however, whether ‘exclusivity’ refers to marketing exclusivity or data exclusivity and does this mean that after all the debate the bill will be amended to seven years?

PhRMA, representing innovative Pharmaceutical Research and Manufacturers of America, responded with disappointment to the President’s budget proposal, stating that this “would diminish crucial incentives for future US medical innovations”.

The GPhA, who represent generic manufacturers, on the other hand, applauded the President for urging that the exclusivity period for branded biologicals be reduced to seven years. They added that “there is no question that a 12-year exclusivity period would provide unwarranted monopolies for brand biopharmaceuticals, which would delay the savings that could result from the earlier introduction of biogenerics”.

Related articles

Twelve-year biologicals exclusivity challenged

US healthcare reform

Source: GPhA, Pharmalot, PhRMA, Wall Street Journal, Whitehouse.

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