House Health Care Bill Includes Biosimilar Licensure Pathway

    By Donald Zuhn --

Last Thursday, Rep. John Dingell (D-MI) introduced the Affordable Health Care for America Act (H.R. 3962) in the House of Representatives.  The 1,990-page bill, which was co-sponsored by Rep. Robert Andrews (D-NJ), George Miller (D-CA), Frank Pallone, Jr. (D-NJ), Charles Rangel (D-NY), Pete Stark (D-CA), and Henry Waxman (D-CA), includes a section (§ 2575) providing for the establishment of a licensure pathway for biosimilar biological products.

With regard to the issue of interchangeability, the bill states that a biological product (i.e., follow-on biologic or biosimilar) shall be determined to be interchangeable with a reference product (i.e., innovator biologic) if information is provided showing that "the biological product . . . is biosimilar to the reference product" and "can be expected to produce the same clinical result as the reference product in any given patient."  Biosimilarity is defined as meaning "that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components," and that "there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product."  For biological products that are administered to an individual more than once, information must also be provided showing that "the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch."

With regard to the issue of data exclusivity, the bill states that a biosimilar application cannot be approved "until the date that is 12 years after the date on which the reference product was first licensed," and further, that a biosimilar application may not be submitted "until the date that is 4 years after the date on which the reference product was first licensed."  The bill also provides an additional 6 months of exclusivity for the use of reference products "in the pediatric population."

Following introduction, H.R. 3962 was referred to the Committees on Energy and Commerce, Education and Labor, Ways and Means, Oversight and Government Reform, Budget, Rules, Natural Resources, and Judiciary, for consideration of the provisions of the bill falling within the jurisdiction of each of the Committees.

Comments

[max hensley]

Well, I guess there is no question about the fix being in since this is now in the Obamacare bill. One more potentially adverse constituency bought off by the Democrats. This bill is turning into a cesspool of corruption.

[EG]

Don,

Given that the health care bill is likely to go nowhere this year (unless there's a huge surprise), having a biosimilar pathway in this bill may be academic for the moment. But it's nice to see a "bipartisan" recognition that granting too short a period of "data exclusivity" could make development of biologic drugs commercially unattractive. Put it this way, as Kevin has correctly said, there is no biosimilar pathway now, so any pathway in this bill is better for FOBs compared with what currently exists.