Health Care Reform: Pathway for Biosimilars
The Facts
The U.S. House Energy and Commerce Committee's health reform legislation, HR 3200, includes a provision to enable the U.S. Food and Drug Administration (FDA) approval of biological products as biosimilars under the Section 351 of the Public Health Service Act. By a vote of 47-11, the Committee adopted the Eshoo-Inslee-Barton amendment that, among other things, would protect original approval data for a minimum period of 12 years. Termed “data exclusivity,” it prevents potential competitors from relying on the innovator’s intellectual property, such as clinical trials supporting the safety and efficacy of the innovator product, to support FDA approval of a biosimilar product.
What’s at Stake
The biosimilar language in HR 3200 is not identical to that agreed to in the health reform bill approved by the Senate HELP Committee. Consequently, there is an opening for additional changes to the provisions related to biosimilars during the House/Senate conference should health reform legislation containing these provisions be passed in both chambers. Stakeholders continue to advocate for changes related to the data exclusivity provisions, which are favored by the Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America but opposed by the generics industry and AARP, which believe shorter exclusivity and more liberal patent protections are necessary to speed lower cost biologicals to patients.
Steps to Consider
Consider selected outreach to Congress or supporting your trade organization's efforts to advocate for more favorable accommodations in the ultimate legislative package. Determine the implications and corresponding business and legal risks from current legislative proposals. Identify steps to take prior to enactment of legislation to best position products going forward, including the following:
- Reimbursement approaches
- Product nomenclature, marketing and labeling
- Issues related to “similar” or "interchangeable" products, including antitrust, intellectual property protection and potential litigation strategies
- Regulatory strategies for pipeline products
