Senators Draft Legislation for Follow-On Biologics Approval

Washington, DC (June 22)-Senators Orrin Hatch (R-UT), Edward Kennedy (D-MA), Michael Enzi (R-WY), and Hillary Clinton (D-NY) agreed on legislation that would authorize the US Food and Drug Administration (Rockville, MD) to approve follow-on versions of biologic therapies. The legislation establishes standards by which FDA would approve follow-on biologics, a means to quickly resolve patent disputes, and incentives that encourage innovation and the development of new therapies.

Announcing the legislation, titled the “Biologics Price Competition and Innovation Act of 2007,” Senator Hatch stated that biologics are the future of medicine. He remarked, “Just as we did with Hatch–Waxman in 1984, we’re giving incentives for both pioneer and generic drug firms. We’re ensuring that we continue to get the latest medical breakthroughs while creating a clear pathway to get less expensive biologics on the market quickly.”

The act would require an applicant to demonstrate the absence of clinically meaningful differences in safety, purity, and potency between its biosimilar product and the brand product. The demonstration includes analytical data, animal testing, and at least one clinical study, unless FDA determines this requirement is unnecessary.

Under the legislation, FDA could approve a biosimilar product as interchangeable, thus allowing it to be substituted for the brand product without the intervention of the prescribing healthcare provider. To demonstrate interchangeability would require evidence that the biosimilar product produces the same clinical result as the brand product in any patient and presents no additional risk in terms of safety or diminished efficacy if a patient changes between products.

As an incentive for the development of new biological products and interchangeable biosimilar products, the act grants 12 years of data exclusivity for the brand company, during which a biosimilar product may not be approved. The act also provides one year of exclusivity for the first interchangeable biological product.

The legislation outlines a process for identifying and resolving patents that the biosimilar product may infringe. The biosimilar applicant and the brand company together would identify the patents at issue and offer their opinions as to their validity. The two parties then would either agree to a list of these patents to be litigated first or exchange lists. The brand company must then sue the biosimilar applicant within 30 days to defend the patents. If a court decides that a patent is valid and was infringed by the biosimilar product before the 12-year data exclusivity has ended, the court must enjoin infringement of the patent until it expires. For identified patents not included in this initial litigation, the biosimilar applicant must give the brand company notice 180 days before it launches its product, and the brand company may then seek a preliminary injunction to block the launch.