March 26, 2007 / 6:00 PM / 12 years ago

Complex generic biologics need more data: FDA

WASHINGTON (Reuters) - Cheaper, generic versions of more complex protein-based drugs will need more data than simpler compounds to prove their safety and effectiveness, a U.S. Food and Drug Administration official said on Monday.

“The amount of assurance and the amount of data that would be needed is really based on how complex something is and how well it can be characterized,” FDA Deputy Commissioner for Operations and Chief Medical Officer Dr. Janet Woodcock told lawmakers.

Other factors, including whether a drug would be used long-term for chronic diseases, will also impact what kind of testing will be needed, she added during a hearing of the U.S. House of Representatives Committee on Oversight and Government Reform.

Her comments come as Congress weighs legislation to give the FDA authority to approve generic versions of biological medicines such as Genentech Inc.’s cancer drugs Herceptin and Avastin, as well as anemia drugs such as Amgen Inc.’s Epogen and Aranesp and Johnson & Johnson’s Procrit.

Unlike conventional, chemical-based drugs, biologics are derived from living cells and are usually injected or infused.

At issue is whether generics could be considered either interchangeable or similar to their more expensive counterparts, and how Congress should set standards.

The FDA already has the power to clear generic versions of traditional medicines. More than 9,000 such products are already on the U.S. market and make up 60 percent of all prescriptions, according to the agency.

Committee Chairman Henry Waxman, the California Democrat who convened the panel, has introduced legislation that would allow the FDA to review generic biologics. A similar bill has been introduced in the Senate.

Brand name drugmakers and other opponents say biologics are too difficult to duplicate and even small differences can affect safety and efficacy. But supporters, including insurers and patient groups, argue competition would make them more affordable than branded versions that can cost tens of thousands of dollars a year.

At the hearing, Woodcock said the FDA has the expertise to evaluate such generics, also known as follow-on biologics, but the ability to compare them to original products will depend on the molecule’s complexity.

Some biologics, such as insulin or human growth hormone, are considered simpler than other proteins used to treat cancer, anemia and other conditions.

“Although this may be currently possible for some relatively simple protein products, technology is not yet sufficiently advanced to allow this type of comparison for complex protein products,” she said in her testimony.

When asked how long it would take technology to catch up, Woodcock said it would be an ongoing process.

“It’s going to be a step-wise progression over a decade or so,” she said.

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