FDA's Rules for Copying Amgen, Roche Drugs Coming `Very Soon'

U.S. regulators plan to unveil rules for reviewing the first copies of biologic medicines “very soon,” according to Food and Drug Administration Commissioner Margaret Hamburg.

The health-care overhaul passed last year included a provision authorizing a process for approving cheaper copies of compounds made from living cells. The FDA is evaluating whether to require extensive clinical trials to judge whether the so- called biosimilars work as well as the products they copy. The outcome may differ from generic versions of common drugs now substituted at pharmacies to keep costs down.

Americans would save $25 billion in a decade through government rules allowing copies of biotech drugs, according to the Congressional Budget Office. The products would be patterned on drugs made by companies such as Amgen Inc. and Roche Holding AG that have been on the market at least 12 years and have expired patents.

“This is critically important,” Hamburg said today in an interview. “We obviously have been thinking about this for some time as different models have been discussed and debated. We will be more formally implementing in the very near-term time frame.”

The FDA isn’t focused on a proposal in the White House budget to shorten exclusivity to seven years to generate additional savings because that would require Congress to change the law, Hamburg said. She declined to say when the first biosimilar products may be approved under the new rules.

‘Creating Competition’

Hamburg is meeting with makers of generic drugs in Orlando, Florida, today as part of the Generic Pharmaceutical Association trade group’s annual meeting. In the absence of final rules, generic companies led by Teva Pharmaceutical Industries Ltd. have been filing the same biologics license applications, or BLAs, used for brand-name drugs, which may not create as much savings for patients.

“The issue is really creating competition,” said Bill Marth, president of North American operations for Petah Tikva, Israel-based Teva. “What we really need, desperately need, to know is what that pathway is so we can stop filing BLAs.”

The FDA asked for more information in September about Teva’s application to sell copies of Neupogen, a drug made by Thousand Oaks, California-based Amgen to fight infections during chemotherapy. Teva is also testing copies of Rituxan, a lymphoma and arthritis treatment from Basel, Switzerland-based Roche and Weston, Massachusetts-based Biogen Idec Inc.

The FDA plans to discuss with industry in the next couple of months how much it will charge to review applications of biosimilar products under the new rules, according to Hamburg.

While the agency charges about $1.5 million for new brand- name product applications with clinical data, generics have been so far exempt from any fees. In exchange for payment, the FDA would offer companies feedback during development and “timely consideration” of whether their products could be automatically substituted for brand-name products, Hamburg said.

To contact the reporter on this story: Catherine Larkin in Orlando at clarkin4@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.

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