Key Members of the House Committee on Energy & Commerce have introduced bipartisan legislation which would create an abbreviated approval pathway for biosimilars or follow-on-biologics (FOBs). The Pathway for Biosimilars Act, H.R. 5629 introduced by Congresswoman Anna Eshoo (D-CA) and committee ranking member Joe Barton (R-TX), enhances the prospects for congressional action in 2008, following Senate HELP Committee action last year on S. 1695, a comparable bipartisan bill introduced by Senators Kennedy, Enzi, Clinton and Hatch.
Last year, final congressional action was delayed by continuing negotiations and differences regarding the extent and scope of data required for approval of biosimilars, interchangeability between biosimilars and the reference innovator product, the role of the FDA in proposing guidance on the submission and licensure of biosimilars, and appropriate periods of data exclusivity for innovator products. However, pressure to enact legislation is mounting again, in part due to the release of the President’s Fiscal Year 2009 Budget calling for “a new regulatory pathway that protects patient safety [and] promotes innovation”, as well as renewed advocacy from the innovator biotechnology industry.
Overview of Pathway for Biosimilars Act Legislation
- Data Required for Approval: Like S. 1695, the Eshoo-Barton legislation requires analytical, animal, and clinical studies to show an FOB is “biosimilar” to the reference product. Both bills also permit such studies to be waived, at the discretion of FDA. However, before waiving clinical/immunogenicity studies, Eshoo-Barton requires FDA to issue guidance on the data requirements for immunogenicity, a provision not in S. 1695. In addition, both S. 1695 and Eshoo-Barton encourage (and in the case of Eshoo-Barton, requires) product or class specific guidance to be issued before approval of a biosimilar.
- Interchangeability: Both S. 1695 and Eshoo-Barton require FDA to make a determination of interchangeability at the time of approval of the biosimilar if the biosimilar can be expected to show the “same clinical result” in “any given patient” as the innovator product, and the risk of switching between the biosimilar and the innovator product is not greater than using the innovator product without switching. Eshoo-Barton, however, requires FDA to issue a final guidance on the scientific feasibility of interchangeability for the product class before the FDA may make a determination that a biosimilar in that class is interchangeable with the innovator product. Moreover, both bills prohibit a second biosimilar from being determined interchangeable with a reference product for a period of time (one year under S. 1695, two years under Eshoo-Barton) after the first biosimilar is determined interchangeable with the same reference product.
- Post-Market Requirements: Both S. 1695 and Eshoo-Barton apply the REMS requirements recently enacted under the FDA Amendments Act of 2007 to biosimilars in the same manner as REMS are applied to currently marketed biologics licensed under the Public Health Service Act.
- Market Exclusivity: Similar to S. 1695, Eshoo-Barton provides for 12 years of market exclusivity for the innovator product. However, the Eshoo-Barton bill goes beyond S. 1695 to include a provision which allows for 14 years of innovator market exclusivity if, within 8 years after approval of the reference product, a new indication for use is approved which would be a “significant improvement, compared to marketed products, in the treatment, diagnosis, or prevention of disease.” In addition, Eshoo-Barton provides for 6 months of exclusivity for approval of a pediatric indication for the reference product.
- Patents: Like S. 1695, Eshoo-Barton includes provisions for resolving patent disputes before the expiration of the innovator product’s market exclusivity period. These include notice requirements and exchanges of information among the FOB applicant, the innovator company, and any third party patent holders, such as a university. Under Eshoo-Barton, if a timely infringement suit is brought following the information exchange and a court determines that one or more patents is infringed, the FOB application cannot be approved until such patents expire. Alternatively, if no such infringement suit is brought, the FOB applicant can sue to resolve any patent disputes as early as three years before expiration of the innovator product’s market exclusivity period.
Conclusion
The introduction of the Eshoo-Barton legislation marks an important milestone in the follow-on biologics debate, particularly in the House of Representatives, where bipartisan discussions are being led by House Energy and Commerce Subcommittee Chairman Frank Pallone (D-NJ) and ranking member Nathan Deal (R-GA). In conjunction with the bipartisan Senate legislation, the Pathway for Biosimilars Act signals an emerging consensus on key issues such as interchangeability and resolution of patent disputes. The result may be an increased likelihood of enactment of comprehensive and balanced legislation creating an abbreviated approval pathway for biosimilars with enhanced incentives for biomedical innovation.
Click here (.pdf) for a more detailed comparison of H.R. 5629 with S. 1695.