In a long-awaited — and some would say long-feared — update in the regulatory pathway for FDA approval of follow-on biologics, the Senate’s Senate Health, Education, Labor and Pensions HELP Committee [1] gave the thumbs up to the Biologics Price Competition and Innovation Act of 2007 (S. 1695) [2], which will address the scientific, regulatory and legal issues involved in bringing generic biologics to the marketplace.
Senators Kennedy, Hatch, Clinton, and Enzi introduced the legislation authorizing the FDA to approve a follow-on version of biologic therapies. The legislation includes standards for the FDA to approve follow-on biologics as well as a period of exclusivity for the brand name drug company. The Act amends section 351 of the Public Health Service Act [3] to provide for an approval pathway for safe biosimilar and interchangeable biological products (relying in part on the previous approval of a brand product):
- A biosimilar applicant is required to demonstrate that there are no clinically meaningful differences in safety, purity and potency between its product and the brand product. A demonstration of biosimilarity includes analytical data, animal testing and one or more clinical studies, unless such a requirement is determined by the FDA to be unnecessary.
- The Act provides incentives for the development of both new life-saving biological products and interchangeable biosimilar products: 12 years of data exclusivity for the brand company during which a biosimilar product may not be approved, and 1 year of exclusivity for the first interchangeable biological product.
- The biosimilar applicant must provide its application and information about its manufacturing process to the brand company. A series of informational exchanges then occur in which the biosimilar applicant and the brand company identify patents in question and explain their views as to their validity or infringement.
Senator Kennedy said the committee plans to attach the bill to the Prescription Drug User Fee Act (PDUFA) [4] reauthorization bill. Sen. Sherrod Brown (Go Ohio!) had drafted an amendment that would have shortened the exclusivity period to seven years but withdrew the amendment without a vote.
Biotechnology Industry Organization (BIO) [5] president Jim Greenwood stated that:
Senators Kennedy, Enzi, Clinton and Hatch deserve credit for their hard work in crafting this complex legislation, and for the bipartisan support they have achieved for the bill. Biotechnology innovators share the goal of ensuring all patients have access to life-enhancing and life-saving biologics. We support the development of a pathway for the approval of follow-on biologics.
Toward that goal, we will continue to work with Congress to make certain the legislation is improved to ensure it supports the principles we have outlined for a pathway to follow-on products, namely providing better protections for patient safety and the patient-doctor relationship.
In addition, the patent litigation rules included in the bill must be revised to improve protections for the intellectual property rights of innovators, ensure timely resolution of all patent disputes and maintain incentives to develop future medical breakthroughs.
Earlier, BIO released a set of principles to guide the development of a pathway for the approval of follow-on biologics [6]. BIO also developed a detailed rationale supporting the need for substantial data exclusivity [7]. Meanwhile, generic manufacturers expressed concern that a 12 year exclusivity for the brand company is too long.
The bill will still need to be passed by the full Senate and the House and then signed by the President.
Read the draft legislation here: Biologics Price Competition and Innovation Act of 2007 (S. 1695) [2].