Clinical Testing Newest Focus in Debate Over Biogeneric Approval Pathway

Biotechnology industry leaders are telling House lawmakers that proposed legislation allowing the FDA to approve follow-on biologics should include clear and sound patient safety provisions.

Responding to testimony at Monday's House Oversight and Government Reform Committee hearing on H.R.1038, the "Access to Life-Saving Medicine Act," Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood emphasized patient safety, saying "responsible science" should drive the debate on creating a pathway for approving follow-on biologics. Greenwood's comments, which came in a letter to committee members, called the legislation "deeply flawed."

Greenwood alleges the bill raises numerous patient safety concerns and alters long-standing patent laws, which favor follow-on biologic producers by allowing them to restrict and infringe on intellectual property rights of innovative biotech firms. He noted that the legislation does not prohibit the FDA from approving a follow-on biologic immediately after approving a reference biologic product.

BIO also weighed in on comparability concerns raised by lawmakers at the hearing. It said that "while the bill defines comparability in a way that purportedly requires the absence of clinically meaningful differences between two products, it adds language that ties this absence of differences to only those differences that can be detected based upon a statutorily limited pool of data: nonclinical studies and -- only if necessary -- clinical studies that must avoid duplicative or unethical clinical testing."

Further, language in the House bill attempts to limit the FDA's ability to require clinical testing, BIO said. The group disagreed with the notion of allowing the federal agency to use clinical testing if that method is the only way to establish the safety and effectiveness of a given follow-on biologic. Instead, BIO supports allowing the FDA to use clinical testing if the method proved to be a "better way" of ensuring patient safety.

Current comparability guidance at the FDA pertains to changes in an already approved biologic product, but has little or no relevance to follow-on biologics, Greenwood noted.

( http://www.fdanews.com/did/6_63/ )