Is close enough good enough for medicine?

Proposal to allow biosimilars takes heat at Congressional caucus hearing

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WASHINGTON, D.C.—At a mid-July hearing on biosimilar drugs, medical experts and policymakers weighed in on rules proposed in the federal healthcare overhaul that would allow an expedited pathway for next-generation biopharmaceuticals to receive fast-track approval by the U.S. Food and Drug Administration (FDA).

The hearing was conducted by the Congressional Health Care Caucus, a group that offers membership only to Republican members of Congress and their staff.

Key to the debate was the proposal to bypass clinical trials for biosimilar medicines.
The FDA was given the authority to approve biosimilar therapies, including drugs that could be considered interchangeable with original formulations, as part of the sweeping healthcare reform legislation, the Patient Protection and Affordable Care Act, signed into law by President Barack Obama on March 23.

Biosimilars, or follow-on biologics, are terms often used interchangeably to describe future generation versions of a biopharmaceutical that had been approved by the FDA under a different drug company. These follow-on compounds often rely heavily on a similarity to the original product, but are produced by another company.

Importantly, biosimilars are complex structures; theoretically, the higher the degree of complexity, the more likely it may be that small changes could impact the overall effectiveness of the drug. The subsequent-generation manufacturer really only has access to the finished product, and not the complex biological structures that were utilized when producing the patented formulation.

It has been the view of many industry experts that the approval mechanism for biosimilars could have as great an impact on the pharmaceutical industry as did the 1984 legislation that permitted generic drugs.

The Democrats' new healthcare reform law included language that resembled an earlier legislative attempt at defining this issue that was sponsored by Rep. Anna Eschoo, D-Calif. The theory then was also to mark a pathway for the FDA to approve next-generation, biologically based pharmaceuticals modeled on original, approved therapies.
Critics then and now claim that the proposed approval process is vague, and could create problems in a multitude of other ways.

The July 19 caucus hearing was concerned primarily with patient safety concerns.
Some experts also argue that due to the complex composition of some drugs and patents on component parts of those therapies, that patent issues could arise. That difference could also result in a tension between enough similarity to win quick FDA approval, yet prove dissimilar enough to stave off claims of patent infringement.

"Biotechnology is the future of medicine," declared Eschoo in a statement issued to ddn. "We're only beginning to scratch the surface of the potential of these powerful drugs. The FDA has both the responsibility and the expertise to determine a drug's safety and efficacy—not drug companies, insurance companies or members of Congress."

Eschoo continued, "As technology evolves, the FDA must have the flexibility to determine the most effective ways to test biologics. The Kennedy-Eshoo legislation requires the FDA to use its expertise to conduct clinical trials for every biosimilar unless the safety, purity and potency can be demonstrated with certainty. The patient protections included in the legislation are the strongest of any considered in Congress and received the broad support of dozens of medical and patient organizations, including the Alliance for Patient Access, the InterAmerican College of Physicians and Surgeons and RetireSafe."

But Craig Kessler, professor of medicine and pathology at Georgetown University, said at the hearing that differences in the way the drugs are manufactured can change the makeup of the therapies that might not be readily evident.

The differences, he said during the Capitol Hill hearing, could manifest themselves "in ways that technology can't detect"—a facet of the debate that could become a concern for patients if their doctors prescribe biosimilars for "off-label" uses.

"If you don't have clinical trials to take a look at all of these other off-label uses," Kessler testified, "then you don't really know what the equivalency in dosing is going to be like, and what the safety—the long-term safety—will be."

Rep. Michael Burgess, R-Texas, a physician who established the Congressional Health Care Caucus, found the hearing to be an opportunity to criticize the Democratic Energy and Commerce Committee for its lack of hearings on the finer points of the healthcare overhaul, and also pointed out that implementation to date has been rocky.

Proponents of biosimilars claim that the provision will also enable expensive therapies to come available at a substantial cost savings.

The federal healthcare legislation creates the pathway for the regulation and approval of biosimilars in the United States, where none had existed before. The United States trails other countries in this regard.

The U.S. Generic Pharmaceutical Association, for example, has identified expensive therapies that would be likely candidates for replacement with new therapies, such as pricey products like Genentech's Avastin, which can cost a patient approximately $100,000 annually. The group estimates cost savings upon adoption of the new therapies on a regular basis could total billions of dollars in short order.

Genentech Spokeswoman Caroline Pecquet, while not willing to comment specifically on the healthcare reform legislation or this specific hearing, issued the following statement on behalf of her company:

"We don't have a comment specific to Rep. Burgess' July 19 panel, but I can tell you that with regard to biosimilars our perspective, first and foremost, is that any legislation must ensure patient safety," she says. "Patients should not have to accept greater risks or uncertainties in using a biosimilar product than an innovator's product. This includes maintaining the physician-patient relationship and allowing only treating physicians to determine whether a biosimilar product is interchangeable for the innovator product."

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