Bipartisan Group Introduces Biogenerics Bill

Lawmakers introduced legislation to create a pathway for the approval of copies of costly biotechnology-based medical treatments.

NEW YORK (AP) -- A bipartisan group in Congress wants to give the Food and Drug Administration power to approve copies of costly biotech drugs.

Rep. Henry Waxman, a Democrat and chairman of the Energy and Commerce Committee, and Republican Nathan Deal introduced legislation to create a pathway for the approval of copies of biotechnology-based medical treatments. Biotech drugs are made in living cells, unlike their chemical-based counterparts.

There is no regulatory process for approving such copies in the U.S. That leaves the drugs' makers insulated from the generic competition the traditional drug industry faces.

President Obama called recently for the creation of a regulatory pathway as part of a plan to reduce overall health care costs.

Well-known biotech drugs include Enbrel for rheumatoid arthritis and psoriasis, made by Amgen Inc., and Avastin, a cancer treatment made by Genentech Inc.

"I believe this bill will lead to healthy competition and long-term savings for patients and payers and will preserve innovation to the biotech marketplace," Waxman said in a statement.

The debate over an approval process for biotech copies has dragged on for years, with both the biotechnology and generic drug industries at loggerheads over how much competition-free marketing the original drugs should get. The biotechnology industry has called for up to 14 years of exclusivity for their drugs before a copy could be introduced.

But the bill instead mirrors the current system for chemical compounds, which allows for five years of market exclusivity for new drugs and up to three years additional exclusivity for modifications.

"This bill seeks to cut prices but instead cuts corners. This proposal leads us off the map as we seek an effective, fair and safe pathway to a biosimilars market," the biotech industry group BIO said in a statement, noting that the molecules in biotech drugs are so complex it is impossible for science to call them "copies."

The bill would give broad authority to the FDA to determine what studies are necessary in order to establish whether any copy is safe and equally effective as the original product. The FDA could also determine whether a biosimilar is interchangeable with the original product.

The proposals go against what many of the largest biotechnology companies want. They are hoping for study requirements for generic companies in order to prove the drugs are safe, along with more market exclusivity.

Biotech drugs are among the costliest for patients, with many costing more than $1,000 per month. A key reason for the cost is the time and money it takes to develop the drugs, the industry has said. Generic companies are concerned that without an abbreviated process for copies, those products will be nearly as expensive as the originals.

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