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