Biologics Legislation
This article was originally published in SRA
Executive Summary
Proposed legislation for follow-on biologics sparks debate in US
Proposed legislation for follow-on biologics sparks debate in US
Proposed legislation to provide a regulatory framework for the approval of follow-on biologics in the US was debated at a hearing of the Senate Committee on Health, Education, Labor and Pensions (HELP) on
8 March 2007. The Access to Life Saving Medicines Act (HR1038) was introduced to the House of Representatives on 14 February 2007 and to the Senate one day later1. [Ed: The bill was first tabled in September 20062, but has been reintroduced following congressional elections in November 2006]. The bill would give the Food and Drug Administration (FDA) the authority to approve follow-on biologics and the discretion to determine what kind of information it needs to ensure that these products are safe and effective. The bill has provoked a debate about how to balance the need for cheaper biologic medicines against the need to reward the proprietary industry for its investment.
Senator Charles Schumer (Democrat - New York), cosponsor of the Senate bill, highlighted the potential reductions in the cost of biologics medicine that this legislation could engender3. He also stressed the need to ensure that the law adequately protects patients, whilst at the same time ensuring that innovation is not stifled by making biologics unprofitable.
On the other hand, the ranking member of HELP, Senator Mike Enzi (Republican - Wyoming), warned against rushing to approve legislation in this area4. He said that it should not be a “drag race to cut costs alone”, but a “careful effort to protect and promote innovation in the marketplace while still ensuring patient safety”. At the hearing, he also rejected calls to link the proposed biologics legislation to the package of FDA-related bills that the committee is preparing, including the reauthorisation of the Prescription Drug User Fee Act. “There are several must-pass related authorisations that Congress must have approved and sent on their way to the President's desk by 3 August 2007 [before Congress breaks for summer],” he said. “Due to the scientific complexity and uncertainty regarding biologics, premature and ill-considered solutions should not be included in the discussion of those must-pass bills,” he added.
The bill
There is currently no statutory pathway in the US for the approval of generic versions of biotech drugs, also known as biosimilars. According to the sponsor of the bill in the House of Representatives, Henry Waxman (Democrat - California), this has resulted in the manufacturers of biotech drugs effectively holding a monopoly and keeping prices artificially high5.
The House bill would amend section 351 of the Public Health Service Act to create a pathway for the approval of biological products “comparable” to the previously approved reference biological product. The bill would require applications for a comparable biological product to show that there are no meaningful differences with the reference product with respect to safety and effectiveness6. Applicants would also have to show that the new product and the reference product contain highly similar “principle molecular structural features” and the same mechanism(s) of action, if known.
Applications would be examined on an individual basis by the FDA to determine what studies are necessary to establish comparability. This could include requesting one or more clinical studies in support of an application. The bill also covers “interchangeability” (the comparable product could be substituted for the branded product at a pharmacy) and allows for the first applicant to obtain approval of an interchangeable version of a biological product to be granted a period of market exclusivity.
References
1. Representative Henry Waxman press release, 14 February 2007, www.henrywaxman.house.gov/waxman/pdfs/biologicspressrelease_2.14.07.pdf
2. Statement of Representative Henry Waxman, 14 February 2007, www.henrywaxman.house.gov/waxman/pdfs/biologicsstatement_2.14.07.pdf
3. Testimony of Senator Charles Schumer, HELP Committee hearing, 8 March 2007, http://help.senate.gov/Hearings/2007_03_08/Schumer.pdf
4. Senator Mike Enzi press release, 8 March 2007, http://help.senate.gov/Min_press/2007_03_08_a.pdf
5 The Regulatory Affairs Journal - Pharma, 2006, 17(11), 766
6. Bill summary of the Access to Life-Saving Medicine Act, 14 February 2007, www.henrywaxman.house.gov/waxman/pdfs/biologicsbillsummary_2.14.07.pdf