Last Friday, Representatives Anna Eshoo (D-CA) and Joe Barton (R-TX) announced the introduction of H.R. 5629, the “Pathway for Biosimilars Act.” We previously reported on a draft version of the bill circulated on Capitol Hill in February 2008. H.R. 5629 will be referred to the House Energy and Commerce Committee where it will presumably be scheduled for a hearing or mark-up session later this year.
Much of H.R. 5629 is similar to the draft version. The bill would amend § 351 of the Public Health Service Act (“PHS Act”) to permit the submission of an application for licensure of a biogeneric that includes, among other things, information demonstrating that the biogeneric is biosimilar to a reference product based on analytical studies, animal studies, and a clinical study or studies sufficient to demonstrate the safety and efficacy of the biosimilar product. While the draft version would have permitted the Department of Health and Human Services Secretary (“Secretary”) to waive only analytical and animal studies (if determined to be unnecessary), H.R. 5629 also permits the Secretary to waive clinical studies (again, if determined to be unnecessary).
As with the draft version, H.R. 5629 provides the sponsor of the first biogeneric determined to be interchangeable with a reference product with a 24-month period of market exclusivity. Innovator companies would get a period of 12-year exclusivity after initial licensure that may be increased to 14 years if during the 8-year period following licensure of the reference product, the Secretary approves a supplement for a “medically significant new indication” that would be a “significant improvement” compared to marketed products. The 12-year or 14-year exclusivity periods may be extended by 6 months by pediatric exclusivity. As is currently the law for pediatric exclusivity applicable to drugs under § 505A of the Federal Food, Drug, and Cosmetic Act (“FDC Act”), H.R. 5629 states that pediatric exclusivity would not apply to a biological product unless FDA determines no later than 9 months prior to the expiration of market exclusivity that pediatric studies submitted to the Agency in response to a Pediatric Written Request meet the terms of the request. Other provisions in FDC Act § 505A would also apply to biologics under H.R. 5629.
New to H.R. 5629 is a provision stating that an application for a biological product must be submitted under PHS Act § 351, except that “an application for a biological product may be submitted under [FDC Act § 505] if - (A) such biological product is in a product class for which a biological product in such product class is the subject of an application approved under [FDC Act § 505] not later than the enactment of [the Pathway for Biosimilars Act]; and (B) such application” was submitted to FDA before the enactment of the Pathway for Biosimilars Act or is submitted to FDA not later than 10 years after enactment. This exception provision is limited so that “if there is another biological product approved under [PHS Act § 351(a)] that could be a reference product with respect to such application” (that is, if such application were submitted under new PHS Act § 351(k) for a biosimilar), then the application may not be submitted under FDC Act § 505. If enacted, H.R. 5629 would also deem an application for a biological product approved under FDC Act § 505 to be a license under PHS Act § 351 on the date that is 10 years after the enactment of the Pathway for Biosimilars Act.
FDA Law Blog will continue to follow H.R. 5629 as it makes its way through the legislative gauntlet.
By Kurt R. Karst