More debate over the exclusivity period for biological in the US

Biosimilares/General | Posted 10/06/2011 post-comment0 Post your comment

The debate over the length of exclusivity that biological drugs can enjoy before competition from biosimilars ensues seems set to be a long and complicated one. The latest group to join in the debate is the Office of the US Trade Representative (USTR).


The USTR is purported to be pursuing stronger patent protection for biological drugs than for conventional medicines in the Trans-Pacific Partnership negotiations, currently being carried out between the US and the Asia-Pacific region.

USTR officials have allegedly indicated that they may propose granting as much as 12 years of data exclusivity for biological drugs, which is in line with what has been proposed by the US healthcare reform legislation.

The US, although it now has a legal pathway (with the approval of the Biologics Price Competition and Innovation Act [BPCI Act], which was signed into law on 23 March 2010 by President Barack Obama), does not yet have a practical pathway with guidance defined by the FDA. This appears to mean that the period of exclusivity has also not yet been ‘set in stone’ – hence the continued debate surrounding the issue.

The issue has major ramifications for different players in the healthcare industry and many different periods have been proposed and different opinions expressed on the subject.

The BPCI Act allows for a pathway for marketing approval of biosimilar medicines, after a period of 12 years of exclusivity for the originator biological.

However, President Obama announced in his 2012 budget a change from the proposed 12-years to a 7-year period of exclusivity for biological and Californian democrat Mr Henry Waxmann has advocated a 5-year period of market exclusivity.

Editor’s Comment

The US is certainly having a thorough debate about the exclusivity period for biological.

Please feel free to share your thoughts via email to or in the comments section below. What are your views on the period of exclusivity originator biologicals in the US should enjoy? How do you think this will affect the biosimilars industry?

Related articles

The history of the US biosimilar regulatory pathway

Exclusivity for biological drugs in the US: what now

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