Moving Toward a Biosimilars Pathway: The Lines are Drawn in Congress

The introduction of two rival bills has intensified the long-simmering debate on biosimilars regulation in the US.
Jul 01, 2009
Volume 22, Issue 7

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March 2009 was an active month for the proposal of legislation that would create a pathway for the US Food and Drug Administration to approve generic biologic drugs, or biosimilars. Two competing bills were introduced into the US House of Representatives, and one into the US Senate, that would provide such a pathway. This biosimilars legislation has been introduced during a time when healthcare reform in the United States, particularly in the area of maximizing affordability of prescription drugs, is receiving increased attention as a primary initiative of the Obama administration.

Rep. Henry Waxman (D–CA) introduced a bill (H.R. 1427) entitled "Promoting Innovation and Access to Life-Saving Medicine Act" in the US House of Representatives on March 11, 2009. This bill, co-sponsored by Reps. Frank Pallone, Jr. (D–NJ), Nathan Deal (R–GA), and Jo Ann Emerson (R–MO), was assigned to the House Committee on Energy and Commerce (chaired by Rep. Waxman) and to the House Committee on the Judiciary. On March 26, 2009, a companion bill (S. 726) was introduced in the US Senate by Sen. Charles E. Schumer (D–NY). This bill, containing the same title and text as H.R. 1427, was co-sponsored by Sens. Susan M. Collins (R–ME), Sherrod Brown (D–OH), David Vitter (R–LA), Debbie Stabenow (D–MI), Mel Martinez (R–FL), and Jeanne Shaheen (D–NH), and was referred to the Senate Committee on Health, Education, Labor, and Pensions, which is chaired by Sen. Edward M. Kennedy (D–MA). According to the bills' text, these companion House and Senate bills are intended "to provide for the licensing of biosimilar and biogeneric biological products . . ."

A second bill having a similar expressed purpose—"to establish a pathway for the licensure of biosimilar biological products"—was introduced into the House by Rep. Anna G. Eshoo (D–CA) on March 17, 2009. This bill (H.R. 1548), is entitled the "Pathway for Biosimilars Act" and was co-sponsored by 44 of Rep. Eshoo's fellow members of the House, with Reps. Jay Inslee (D–WA) and Joe Barton (R–TX) being primary co-sponsors. H.R. 1548 also has been referred to the House Committee on Energy and Commerce and to the House Committee on the Judiciary.

By their titles and their expressed purposes, H.R. 1427 ("the Waxman bill") and H.R. 1548 ("the Eshoo bill") appear to have a common goal—to provide a mechanism for the review and licensing by the FDA of generic biotherapeutic products (also sometimes referred to as "biogenerics" or "follow-on biologics," but referred to as "biosimilars"). Because S. 726 is a companion bill to, and contains the same text as, H.R. 1427, this article will focus on the differences between the two House bills. It seems likely that because both bills have been introduced into the House Energy and Commerce Committee and Judiciary Committee, the real negotiations for a final bill will take place within those House committees and the final Senate bill would conform to the bill emerging from the House.

By their provisions, however, these two competing House bills set out to achieve a common goal in very different ways, setting up drastically different regulatory schemes for the approval of biosimilars. The introduction of these rival bills has intensified the long-simmering debate between various groups having an interest in biosimilars regulation. This includes high-profile individuals from the generics pharmaceutical industry and the biotechnology industry, and even certain members of Congress, who have spoken out in recent weeks on the merits and demerits of these two bills. Of interest to both sides in the debate is the fact that this discussion is taking place at a time when the biopharmaceutical industry is not only beginning to deliver its long-promised benefits in the treatment and prevention of certain diseases, but also when the industry is increasingly being viewed as the "savior of the pipeline" for many traditional pharmaceutical companies.

This article will examine some of the primary differences between these competing bills, focusing on the provisions that have received the most attention in the trade and popular press. The article will also compare the provisions of these bills to the regulatory scheme currently in place for traditional or small-molecule pharmaceuticals, better-known as the Hatch-Waxman Act, which has provided a mechanism for the review and licensing of generic pharmaceutical products for the last 25 years.1 Finally, the article will note some of the public comments made by individuals on both sides of the debate.

This article does not intend to advocate for one proposed regulatory scenario over another, but instead attempts to provide an overview of the key provisions of these bills so that the key constituencies involved in the biopharma* industry can remain informed as the legislative process evolves.

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