By Kevin E. Noonan --
Members of Congress having sent their letter to the Food and Drug Administration on December 21st (see "Representatives Send Letter to FDA to Explain Data Exclusivity Provisions of Biosimilars Legislation"), on January 7th, it was the Senate's turn. In their letter, Senators Kay Hagan (D-NC), Orrin Hatch (R-UT), Michael Enzi (R-WY), and John Kerry (D-MA) address the same provisions of the Act and give the Agency substantially the same message as to their "intent" in passing the legislation that their House colleagues did two weeks earlier.
Agency action that prompted the Senators' letter was the portion of the Public Notice in the Federal Register requesting public input (significantly from the innovator and biosimilar communities) regarding the meaning of the term "exclusivity" in the statute (Patient Protection and Affordable Care Act (P.L. 111-148)):
What factors should the agency consider in determining whether a modification to the structure of the licensed reference biological product results in a change in safety, purity, or potency, such that a subsequent Biologic License Application (BLA) may be eligible for a second 12-year period of marketing exclusivity?
Like their colleagues in the House of Representatives, the Senators assert that "[t]he Act does not provide market exclusivity for innovator products." Rather, the exclusivity referenced in the Act is data exclusivity, "which prohibits FDA from allowing another manufacturer of a highly similar biologic to rely on the Agency's prior finding of safety, purity and potency for the innovator product," qualified by the phrase "for a limited period of time." The Senators, like the MOCs, make the distinction that the biosimilar manufacturer is not prohibited from "developing its own data to justify FDA approval of [its own BLA] rather than an abbreviated application that relies on the prior approval [and data] of a reference product."
The letter also reminds the Agency that the Act does prohibit it from granting more than one period of data exclusivity to the innovator (but not, of course, to the putative follow-on biologic manufacturer who undertakes filing its own BLA, which upon award would benefit from its own 12-year data exclusivity period). This is clear from the qualifiers "from the same company" included in the letter's synopsis of these provisions of the Act:
The Act explicitly precludes any period of data exclusivity for the following:
o A supplement to a BLA; or
o A subsequent BLA (from the same company) for a non-structural change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength; or
o A subsequent BLA (from the same company) for a structural change that does not result in a change in safety, purity or potency.
Like the letter from the House members, the Senators' letter closes with a statement that "the Act provides incentives for innovators to research and develop new treatments for patients," including an innovator company that "modifies an approved product to produce a change in safety, purity or potency [presumably, for the better]." Approval of such a "new [drug] product" will not change the data exclusivity for the "first-generation" product (which will expire "as usual"), but will be entitled to its own 12-year data exclusivity period like all new biologic drug products.
While it might be easy to dismiss this letter (like the MOC's earlier letter) as unadorned politics (particularly since both letters are not binding on the agency or a reviewing court in implementing or interpreting the statute), it does reflect bipartisan consensus on these issues. The letters proffer a definition of "exclusivity" that attempts to prevent "evergreening" while fostering innovation, and to encourage an alternative path for biosimilar approval for those biologic drugs having sufficient market profit potential to justify the effort and expense of avoiding the innovator's data exclusivity by producing its own. The combination of interpretations may also encourage development of "bio-betters," but that may also require the FDA to make decisions on questions such as the meaning of the terms "highly similar" and "interchangeable" that (unlike the meaning of "exclusivity") Congress has left to the agency's discretion and the exercise of its expertise.