Republicans urged Congress and the FDA Monday to consider patient safety issues when establishing an approval pathway for generic versions of biologic drugs.

The panel, hosted by Rep. Michael Burgess, R-Texas, focused on provisions of the healthcare overhaul law that authorize the FDA to approve generic biologic drugs, often called biosimilars or follow-on biologics. Biologics are complex pharmaceuticals that are often made from living organisms.

"This is the hearing I never got in my committee," said Burgess, referring to the House Energy and Commerce Committee, where the biologics provisions originated, "so we can make certain there is a process, an appropriate level of oversight for biosimilars."

Much of the debate surrounding biologics during the writing of the healthcare law focused on how long brand-name pharmaceutical companies should have patent protection from generic challenges. The bill ultimately granted the pharmaceutical industry 12 years of "data exclusivity," several years longer than the generics industry had lobbied for.

But while Burgess and his panelists said the intellectual property portions of the law were strong, they expressed concern over the power of the FDA to approve biosimilars without demanding that generic pharmaceutical companies conduct clinical trials on their products.

"The law gives the FDA an awful lot of latitude and flexibility," said Merrill Matthews, a health policy expert for the Institute for Policy Innovation, a conservative think tank. "If approval can be done without clinical trials, I am concerned about the lack of clarity on the safety issues."

The law allows the FDA to determine that a biosimilar drug is "interchangeable" with a brand name drug if the treatment is "expected to produce the same clinical result" as the brand name drug, but the legislation does not exactly define the test for biosimilarity.

The FDA is expected to begin holding public meetings later this year to solicit comment on how the process should work. Burgess called on Energy and Commerce Chairman Henry Waxman to hold hearings to examine the FDA's implementation of the law.

Craig Kessler, a professor at Georgetown University's Medical School, said he had "lived through several examples" of complex drugs that did not get clinical trials for FDA approval that resulted in adverse events. Kessler pointed to red blood cell epoetin drugs that were produced differently than the original products and that ultimately made some patients sick. The FDA eventually issued safety warnings for several epoetin products.

"As a physician, I am very much in favor of having biosimilars in the marketplace. But what I'm here to emphasize is that we don't want to sacrifice patient safety to decrease the cost of care," said Kessler, "and manufacturing processes may modify these drugs that technology cannot detect."

But some health policy experts argue that regardless of what approval pathway the FDA establishes, generic drug companies might be better off arguing their products are entirely unique to brand-name drugs, given the long period of exclusivity that brand-name drugs have.

"The barriers to follow-on entry, like greater manufacturing costs and the proof of biocomparability, are already higher for biologics. If companies have to wait 12 years, they might be better off arguing that their molecule is unique enough to be a different drug," said Anthony So, director of Duke University's health policy program.

"This would have defeated the whole purpose of providing an abbreviated generic pathway for follow-on biologics."


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