The counter-intuitive political dynamics of the follow-on biologics debate in the House Energy and Commerce Committee are on full display with the introduction of a bill from Rep. Anna Eshoo, D-Calif., and Joe Barton, R-Texas.

Introduced March 13, H.R. 5629 creates a minimum 12-year exclusivity period for brand biologics and offers a mostly guidance-based approach to approving interchangeable versions. The bill is not substantially changed from a previous draft (¹ Also see "Biogenerics Bill From Reps. Eshoo And Barton “Expects” Limits On Substitution" - Pink Sheet, 25 February, 2008., p. 3).

The introduction did reveal, though, the extent of formal support on the Commerce Committee for legislation that has been praised by the brand industry and panned by generic firms. Ten of the 14 co-sponsors of H.R. 5629 are on the committee, with seven, including Eshoo and Barton, on its health panel.

And while Democrats are often seen as allies of generic firms and Republicans friends of the brand industry, two other Democrats have joined Eshoo on the bill.

Another bill supported by the brand industry, H.R. 1956, from Rep. Jay Inslee, D-Wash., enjoys even more Democratic support. Seven of the 17 co-sponsors are Commerce Committee Democrats; four are on the health subcommittee and another three sit on the full committee, as does Inslee.

Rep. Baron Hill, D-Ind., is the sole committee member to back both Eshoo's and Inslee's bills.

"Passionately" Held Positions

Eshoo and Inslee both represent districts with substantial biotech presence. At the Generic Pharmaceutical Association's annual meeting last month, outgoing GPhA Chairman Bruce Downey, of Barr, noted the "unusual set of alliances in the House." And he grudgingly acknowledged that "like congressmen are supposed to do, they represent their constituent interest."

While Eshoo's bill has the fewest co-sponsors at the moment, the presence of Barton, the full committee's ranking member, gives it substantial heft.

If Health Subcommittee Chairman Rep. Frank Pallone, D-N.J., introduces a new bill, however, that could be the most significant one. In a statement, Pallone said he plans to "continue my work with Congressman Deal to develop consensus among the subcommittee members so we can move a bill forward." Rep. Nathan Deal, R-Ga., is the subcommittee's ranking member.

Pallone's objections to Eshoo's bill include the length of exclusivity - it "would negatively impact competition in the marketplace" - and the approval framework for biosimilars - "it could cause unnecessary delays."

Pallone already co-sponsors another bill, H.R. 1038, introduced by Rep. Henry Waxman, D-Calif., last February (² Also see "Generic Biologics Bill’s Key Battleground May Be Senate Health Committee" - Pink Sheet, 19 February, 2007., p. 3). That measure provides no exclusivity for brand biologics and sets few specifics about the data required to justify approval of a biosimilar.

Although sponsored by 28 House members, only two of them - Waxman and Pallone - sit on the Commerce Committee.

Whether a law can be crafted during an election year remains in doubt. As health panel member Michael Burgess, R-Texas, noted during an interview with "The Pink Sheet," there are people on both sides of the issues who "feel passionately" about their positions. He pointed out, however, "there is some energy behind a consensus being built."

The challenge for Pallone will be to craft legislation that can win over the committee while still tilting the policy seesaw more towards generics than Eshoo's bill does.

Pushing against Pallone's desire for more limited exclusivity is approval by the Senate Health, Education, Labor and Pensions Committee of S. 1695, which allows 12 years of exclusivity for brand products (³ Also see "Biosimilar “Interchangeability” Standard Is Double-Edged Sword For Generics" - Pink Sheet, 2 July, 2007., p. 3).

HELP Committee leaders Edward Kennedy, D-Mass., and Michael Enzi, R-Wyo., are awaiting action by the House before taking their measure to the Senate floor.

Eshoo's final bill includes a change from the February draft that provides more flexibility for generic applications. FDA could now waive the requirement for clinical studies to support a biosimilar application if they are deemed unnecessary. However, the bill retains the requirement that waivers for clinical studies of immunogenicity would be allowed only if there is final guidance on such waivers.

- Cathy Dombrowski (c.dombrowski@elsevier.com)

Biosimilars Bill From Reps. Eshoo, Barton Gathers Steam In House Cmte.

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