Biosimilars will be challenging for FDA, speakers say

The Food and Drug Administration (FDA) will face a number of challenging issues as it works to create a pathway to bring generic versions of biologics into the market, speakers said at a Brookings Institution panel Wednesday morning.

The healthcare reform law allows for the approval of so-called biosimilars after 12 years of patent exclusivity. However, critics have warned that the law provides the FDA with too much leeway to approve these drugs — including the flexibility to decide if clinical trials are even necessary.

Biologics are medications and other medical products created through the biological process instead of chemistry. Experts have warned that the biosimilar manufacturing processes can alter the drugs in ways that cannot be detected.

Mary Pendergast, president of a biotech consulting firm, said the 12-year approval process raises the question of whether a generic biologic will be consistent with the original drug.

"If you have a pioneer in year 12 that has a product different from the biologic that was tested for a biosimilar in year two or three, at year 12, are they going to be biosimilar or not?" she said.

The FDA is being asked to make "very tough scientific decisions" over whether one drug is biosimilar to another drug, Pendergast said, adding that she expects Congress will continue to battle the FDA over requirements for the biosimilar approval process.

"Members of Congress have already told the FDA what they think they should do, which may or may not be identical to law as written," Pendergast said. "The FDA will be under pressure from the innovator and biosmilar industries one way or another. This is very difficult to the FDA."