Washington Editor

WASHINGTON - Capping a busy legislative week, a new follow-on biologics bill debuted late last week, and it certainly seems palatable to pioneer drugmakers who have resisted previously introduced legislation on follow-ons.

The alternate language is written to protect innovation and assure patient safety in creating an abbreviated approval process, according to the new bill's chief sponsor, Rep. Jay Inslee (D-Wash.). It's also aimed at establishing different approval standards for different classes of biologicals, depending on complexity.

"It's a positive step forward," said Sandi Dennis, the deputy general counsel for health care regulatory affairs at the Biotechnology Industry Organization, though she said BIO is continuing to absorb the bill's subtleties and awaiting member company feedback. "It addresses many of the issues that we think are important."

Inslee, a member of the House Energy and Commerce Committee that oversees the FDA, represents a Seattle-area district that includes a strong biotech presence in Bothell, Wash.

Among such companies with business operations there is Amgen Inc., a leading opponent of the older follow-on bill put forth by Sens. Charles Schumer (D-N.Y.) and Hillary Rodham Clinton (D-N.Y.), along with Rep. Henry Waxman (D-Calif.).

In contrast to that prior proposal, Dennis praised the new bill for taking into account "the differences between drugs and biologics." Many of its components generally meet standards for which BIO has advocated on that issue, and in many ways, it follows the groundwork laid by regulators in Europe.

Called the Patient Protection and Innovative Biologic Medicines Act, or H.R. 1956, it mandates preclinical and clinical studies, evaluations of immunogenicity, as well as post-approval follow-up testing, to demonstrate the safety of follow-ons.

The bill also assigns unique names for follow-ons, distinguishable from similar biologicals, and prohibits interchangeability with reference products, though it allows biannual reviews to determine whether interchangeability has become possible. In that regard, H.R. 1956 acknowledges that true generic versions of biologics are not feasible. Labeling them biosimilars recognizes their similarities, but stops short of intimating sameness with original reference products.

In addition, the new bill provides 14 years of data exclusivity for pioneer products, with an additional year available if a new indication is approved during the 12 years after the reference product's initial authorization. Also, there would be no disclosure of pioneer manufacturing trade secrets and nonpublic safety and effectiveness data, though a summary of safety and effectiveness data could be released after the first follow-on approval relying on the reference product.

Lastly, H.R. 1956 requires the FDA to issue guidance describing the data that will be required for the approval of follow-ons in a particular product class.

Such guidances will involve stakeholder participation and advice from a proposed advisory committee on similar biological products, creating a process to allow the FDA to make determinations about the data and information needed for follow-on approvals based on the complexity of the original products.

In contrast, the Schumer-Clinton-Waxman proposal does not require clinical testing of follow-ons, instead giving the FDA case-by-case flexibility to determine if they're needed, and provides no data exclusivity for pioneer products.

Known as the "Access to Life Saving Medicine Act of 2007," or H.R. 1038 and S. 623, it also includes a mechanism for interchangeability. (See BioWorld Today, Oct. 3, 2006.)

It's not yet known if companion legislation to Inslee's bill will arise in the Senate, where pretty strong signals have recently indicated that follow-on language will get incorporated into a wide-ranging FDA bill that's cleared committee. Called the "Food and Drug Administration Revitalization Act," or S. 1082, it principally deals with renewing the Prescription Drug User Fee Act (PDUFA) and authorizing new safety powers for the FDA. (See BioWorld Today, April 19, 2007.)

Dennis said BIO is continuing to fight against including follow-on language in S. 1082.

Efforts to reconcile Inslee's bill with the Schumer-Clinton-Waxman proposal could come out of a future hearing on follow-ons, expected to be scheduled at some point by the Energy and Commerce health subcommittee. Inslee's co-sponsors include Reps. Gene Green (D-Texas) and Tammy Baldwin (D-Wis.), both of whom serve on that subcommittee.

Senate Doesn't Consider Part D Change

Lawmakers last week voted against full Senate consideration of a bill to strike the non-interference clause in the Medicare Modernization Act, regarding the Part D drug benefit. The measure, the "Medicare Prescription Drug Price Negotiation Act of 2007," or S. 3, cleared the Senate Finance Committee a week earlier. In addition to permitting government negotiations on Part D drug prices, the proposal also provides for more pricing transparency and calls for comparative effectiveness studies.

Critics believe the legislation would limit patient access and lead to price controls. The House already passed a bill that mandates government negotiations on Part D drug prices, but with no Senate version moving forward, there's no need to conference.

EPO Pricing Still Under Microscope

Rep. Pete Stark (D-Calif.) last week circulated a letter to fellow congressional members charging that for-profit kidney dialysis facilities are administering Amgen's erythropoiesis-stimulating agents Aranesp and Epogen at higher-than-needed doses because of their "direct financial incentive" to do so, to the detriment of Medicare's reimbursement system.

That's not a new allegation, but as Congress continues to scrutinize drug pricing across the board, it bears continued watching. The health subcommittee of the House Ways and Means panel, of which Stark serves as chairman, has scheduled a hearing on Medicare's financial well-being this week, and it seems the issue could come up.