Congress pushes for biosimilars pathway

March 2009 saw the US Congress turn its attention to the issue of creating a regulatory pathway for biosimilars (see p. 11). However, two competing visions have emerged, both originating in the House of Representatives, and predictably, one is favoured by the generics industry whilst the other is favoured by the biotech industry. First out of the blocks was a bipartisan bill, H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act, introduced by Henry Waxman, Nathan Deal, Frank Pallone and Jo Ann Emerson. With Mr Waxman‟s name on the bill, it is no surprise that the generic industry favour this bill. However, within days, a second bill, H.R. 1548, the Pathway for Biosimilars Act, was introduced, again by a bipartisan group of representatives, including Anna Eshoo, Jay Inslee and Joe Barton. This bill has won the approval of BIO.

Both bills are broadly similar, basically attempting to set out a regulatory pathway on the same lines as the Hatch-Waxman Act. However, there is one essential difference between the two: H.R. 1427 gives original biologics five years of exclusivity, with certain modifications of existing drugs getting three years. These periods can be extended for up to a year. Meanwhile, H.R. 1548 provides up to 14 ½ years of data exclusivity for new biologics. It is clear why the generics industry would favour one bill whilst the biologic industry would favour the other. This also suggests the two competing bills are the result of lobbying by the various industry interests. This is backed up by the fact that Representative Inslee represents a Seattle-area district with a strong biotech sector. In addition, Mr Inslee also serves on the House Energy and Commerce Committee, as does Ms Eshoo and Mr Barton, who is the ranking member of the committee. However, the committee is chaired by Mr Waxman, who can also call on support from his cosponsors, Mr Pallone and Mr Deal, so clearly the two bills will be the subject of considerable debate. How the two bills fare in the committee stage will be an interesting battle of wills.

Outside of Congress, the various proponents and opponents of the two bills have shown differing approaches in how they are trying to sell their arguments. BIO has said that it has safety concerns over H.R. 1427, whilst applauds the alternative bill, H.R. 1548, for being safer. However, it seems likely that BIO‟s more immediate concern is over the length of data protection, which is a legitimate concern for the industry, but not necessarily one that will fly with the general public. BIO also expresses concern that H.R. 1427 would jeopardise biotech jobs, noting that the industry supports 7.5 million jobs in America, with these jobs generally being highly paid, and therefore good contributors to the economy. Conversely, the GPhA also uses the economy angle in its support of H.R. 1427, arguing that the bill would help the economy by strengthening healthcare whilst reducing costs to the public. The GPhA adds that the bill is supported by consumer, business and labour organisations. Both sides recognise that a regulatory pathway for biosimilars is inevitable. However, what shape that legislation will ultimately take is less clear, and will seemingly depend on political skills and an ability to convince public opinion.

Ian Platts - Editor, World Generic Markets

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

President-elect Obama begins to select administration members

The election of Barack Obama to become the next President of the United States at the start of November will potentially result in changes for the healthcare industry. Mr Obama had previously indicated his support for increasing access to generics as a means to reduce healthcare costs in the run up to the election, and on his www.change.gov website, the Obama-Biden Plan on healthcare reform includes plans to reduce costs for American families by, "Lower(ing) drug costs by allowing the importation of safe medicines from other developed countries, increasing the use of generic drugs in public programs, and taking on drug companies that block cheaper generic medicines from the market."

Not surprisingly, both the Generic Pharmaceutical Association (GPhA) and Pharmaceutical Research and Manufacturers of America (PhRMA) have congratulated Mr Obama on his election victory. Equally unsurprisingly, the GPhA has taken the opportunity to remind Mr Obama of his commitment towards increasing access to generics, adding that at the GPhA’s Annual Policy Conference in September, Mr Obama’s health policy advisor added that Mr Obama would also address issues including citizen petitions, free trade agreements and authorised generics as part of his healthcare agenda. The GPhA also added that the President-elect had also expressed support for biosimilars, noting that his campaign had stated that, as President, Mr Obama would support legislation to create a biosimilar approval pathway with as short an exclusivity period as possible to ensure timely consumer access. PhRMA had perhaps less to remind the President-elect of, but commented that the organisation would continue to work with lawmakers on both sides of the aisle and would continue to support policies that encourage and strengthen innovation, improve patient access to medicines and expand healthcare coverage.

Of course, Mr Obama’s administration is still taking shape, and the President-elect will not formally announce the administration until closer to his inauguration in January 2009. However, he has already apparently made a couple of appointments that will be of interest to the healthcare industry in general. Mr Obama has appointed Tom Daschle to be the new HHS Secretary. Mr Daschle, formerly a lawmaker for South Dakota, had been Democratic leader before losing his seat in the Senate in 2004. Mr Daschle had been an early supporter of Mr Obama.

Perhaps more interesting is news that Henry Waxman is to be appointed Chairman of the House Energy and Commerce Committee. PhRMA issued a statement on 20th November 2008 welcoming the chance to work with Mr Waxman, as it had also done for Mr Daschle the day before. However, it would be hard to imagine that PhRMA would have received this news with much enthusiasm. Mr Waxman, co-author of the Hatch-Waxman Act, has long been a supporter of the generic industry, although as the Hatch-Waxman Act has shown, he has been careful to balance this with considerations for the needs of the innovator industry. Mr Waxman has made no secret of his support for improving access to both generic and biosimilar medicines, and will now be chairing a committee that has oversight on healthcare issues. It will be interesting to see what the coming four or eight years will bring.

Ian Platts - Editor, World Generic Markets