Washington Editor

WASHINGTON - It appears that the FDA will conduct certain business surrounding guidance for follow-on biologics in public, a decision that pleases the Biotechnology Industry Organization.

BIO recently sent the agency a six-page letter reiterating an earlier point made in its 70-page citizen petition asking the FDA to seek scientific and other outside expertise before changing the way it regulates or approves biologics. (See BioWorld Today, April 28, 2003.)

Washington-based BIO said the FDA formed a follow-on biologics working group to develop draft guidance regulations describing scientific methods for determining the "sameness" or "similarity" of two biotechnology products made through different manufacturing processes. The problem here is that the FDA said the group is basing some of the guidance on knowledge it has gained through its review of innovator comparability data.

Michael Werner, BIO's chief of policy, told BioWorld Today such practices violate trade secret law.

"Our view is that the FDA cannot rely on an innovator's proprietary data to approve a follow-on biologic," he said.

Genentech Inc., of South San Francisco, agrees.

In a 28-page citizen petition sent in April, the company said foremost in any discussion about follow-on biologics must be the legal principles establishing and protecting the trade secret and confidential information contained in a drug application.

"The FDA has gained a tremendous amount of knowledge about biotechnology-derived products and the way they perform in the human body through reviewing trade secret and confidential commercial data and information of companies like Genentech," the petition said. Genentech could not be reached for comment.

Genentech said it doesn't appear that the FDA has an administrative process to prevent unauthorized use or reliance on trade secret or private information when reviewing applications submitted by non-innovators.

Whatever the case might be, it looks as if it will be hashed out in public. Both scientific and legal meetings are expected on the topic.

"We have been calling for this for a while," Werner said, adding that the agency had first resisted.

The subject of follow-on or generic biologics and whether the biotechnology industry would find itself in the wide arms of the Hatch-Waxman Act of 1984 (legislation that created the generic drug industry) has been a matter of discussion for some time. And there are problems.

As stated by Genentech in its citizen petition, the company does not believe that current science allows for reliance on analytical data and information generated from one biotechnology-derived product to support approval of a product manufactured through a different process.

Generics are products approved under an abbreviated new drug application, meaning clinical study is not required.

"No one is suggesting that there be a similar process for biologics," Werner said. "It is unclear what the process would look like for follow-on biologics. But what does seem to be clear is that the ANDA process for small molecules under [FDA regulations] is not expressly applicable for biologics.

"We argue that the science is such that clinical trials are necessary in order to demonstrate safety and effectiveness of a follow-on biological product, so we are certainly pleased that the FDA is moving in that direction," he said.

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