A bill that would allow the Food and Drug Administration (FDA) to approve similar versions of already-approved biologic drugs was introduced on March 11, 2009, by House Energy and Commerce Committee Chairman Henry Waxman (D-Calif.), and Reps. Frank Pallone (D-N.J.), Nathan Deal (R-Ga.), and Jo Ann Emerson (R-Mo.). The bill, H.R. 1427, is titled the "Promoting Innovation and Access to Life-Saving Medicine Act." Currently, biologic drugs are among the most expensive; the bill's co-sponsors seek to reduce costs by promoting market entry of competing biologics. Like Chairman Waxman's bill last year, the provisions of H.R. 1427 are closer to those espoused by the generic drug industry than to those advocated by brand biologics. A companion bill is expected to be introduced in the Senate by Senators Chuck Schumer (D-N.Y.), Susan Collins (R- Maine), Sherrod Brown (D-Ohio), and David Vitter (R- La.).
As early as the week of March 16, Reps. Anna Eshoo (D-Calif.), Joe Barton (R-Texas), and Jay Inslee (D-Wash.) are expected to introduce a competing approach, with provisions anticipated to be more aligned with those advocated by the biotechnology industry. Provisions of both H.R. 1427 and the Eshoo/Barton/Inslee draft measure are described further below.
"Promoting Innovation and Access to Life-Saving Medicine Act," H.R. 1427.
H.R. 1427 would set up a system for FDA approval of follow-on biologic drugs analogous to the system for generic drug approval under the so-called "Hatch-Waxman" Act, which authorizes the FDA to approve a "generic" drug application if the generic can show its bioequivalence to an already-approved brand drug and patent issues have been addressed under specified procedures. This abbreviated approval eliminates the need for costly and time-consuming studies on the generic drug.
H.R. 1427 similarly would enable expedited FDA approval of a follow-on, or similar, version of a branded biological product, but the bill's provisions differ from those of the Hatch-Waxman Act. Biologics are far more complex than the drugs approved under Hatch-Waxman, and the biotechnology industry and generic drug manufacturers have vigorously debated the circumstances under which a follow-on biologic should be approved to compete with an already-approved biologic.
Among other elements, Chairman Waxman's bill would:
(1) allow five (5) years of market exclusivity from the date of FDA approval of the brand biologic drug, with an additional three (3) years of market exclusivity for modifications to the drug in certain circumstances;
(2) define "biosimilarity" to mean that "no clinically meaningful differences between the biological product and the reference product [i.e., the original biologic drug] would be expected in terms of the safety, purity, and potency if treatment were to be initiated with the biological product instead of the reference product";
(3) in addition, permit biosimilar manufacturers to demonstrate "interchangeability" if switching between the biosimilar and reference product can be accomplished "without an expected increase in the risk of adverse effects, including a clinically significant change in immunogenicity, or diminished effectiveness, compared to the expected risks from continuing to use the reference product without such switching";
(4) require the FDA to issue guidance on the "standards and requirements for interchangeability" within two (2) years of passage of the bill, but allow determinations of "interchangeability" to be made before the issuance of that guidance; and
(5) establish procedures for the resolution of patent disputes before a biosimlar is approved, including significant restrictions on the remedies available to patent holders and strict time limits that would obligate parties to litigate patents in a timely fashion.
"Pathways for Biosimilars Act," (the Eshoo/Barton/Inslee draft measure)
Reps. Eshoo, Barton, and Inslee are presently seeking co-sponsors for the "Pathway for Biosimilars Act." Although the draft bill may change before introduction, the bill in current form would, among other things:
(1) allow twelve (12) years of data exclusivity for the reference biologic drug, with additional years granted under certain circumstances;
(2) require the FDA to issue final guidance on a product class basis, after opportunity for public comment, for approval of biosimilars, and to establish a process through which the public could provide input regarding priorities for issuing such guidance;
(3) require the FDA to issue final guidance on a product class basis before approving an application to market a product based on its biosimilarity to a reference biologic in the product class; such biosimilarity would need to be established through specific types of studies, of which analytic, animal, and clinical studies could be waived in certain circumstances, but immonogenicity studies could not be waived absent final guidance on this issue;
(4) require the FDA to issue final guidance on the feasibility of demonstrating "interchangeability" before a biosimilar could be approved as "interchangeable" with a reference biologic; and
(5) establish a process for the resolution of patent disputes before a biosimilar is approved.