Biosimilars in the US a step closer?

President Obama has released his budget proposals, including those for the Department of Health and Human Services. The proposal would provide US$76.8 billion to the HHS, whilst the FDA is requesting nearly US$2.4 billion, an increase of 5.7% over the budget that the agency received for the current fiscal year. Not surprisingly, much of the focus on the healthcare aspects of the budget have been on the headline-grabbing issues, such as healthcare reform and the doubling of funding for cancer research. However, another aspect of the budget which deserves attention is its proposal to establish a regulatory pathway to approve generic biologics.

This has long been a thorny issue for the United States with the result that the country has lagged behind the European Union, where a basic approval pathway for biosimilars has been hammered out. Progress on the issue in the US has never been forthcoming, with the opposing sides of the argument clashing on all issues surrounding biosimilars, from their safety and efficacy to the length of data exclusivity periods for biologic products. Whilst none of the parties may have actually said that they do not want biosimilars allowed, the efforts to torpedo any attempt to create a pathway have spoken volumes.

With the new budget proposal specifically seeking to create a regulatory pathway, the question of whether this logjam can be broken has to be asked. President Obama has a focus on healthcare issues in general, with an intention to make the system more cost-effective and widen coverage for more Americans. Mr Obama’s nomination, albeit a second attempt after Tom Daschle, of Kathleen Sebelius, currently the Governor of Kansas, to the post of Secretary of Health and Human Services can be seen to underscore a determination to make changes. Ms Sebelius is a popular Democratic governor in a Republican-dominated state, a position which suggests that bipartisan working has been an essential element of Ms Sebelius’ job, and in turn suggests the same approach will be used should she become the head of the HHS. Thus the job would be taken by somebody with experience in successfully negotiating between staunchly opposed interests, which would surely be essential in any effort to produce a working regulatory pathway for biosimilars. Prior to this nomination, Henry Waxman was voted by the Democratic Caucus to become Chairman of the Committee on Energy and Commerce, which will have oversight on healthcare issues. Mr Waxman has long been known to support establishing a regulatory pathway for biosimilars, and his appointment must surely up the ante.

However, this is an issue which has long confounded its advocates, and whilst the political landscape may have moved to more fertile grounds for creating a pathway, the arguments against it have not been diminished. The issue of biosimilar safety will continue to be a problem, particularly for a litigious nation; entrenched arguments over data exclusivity will not now go away, and the savings through generic biologics will still be pitted against costs to American innovative companies and their employees. The push to create a pathway may have taken one step forward, but there still remains plenty of opportunity for its opponents to claw two steps back.

Ian Platts - Editor, World Generic Markets