FTC releases biosimilars report, examines effeciency of FDA approval

6/10/2009

WASHINGTON Giving the Food and Drug Administration authority to approve biosimilars would be an efficient way to get them to market and lower consumers’ healthcare costs, but wouldn’t result in a dramatic competitive environment like generic pharmaceutical drugs, according to a report released by the Federal Trade Commission Wednesday.

The FTC report, titled “Follow-on Biologic Drug Competition,” examined whether the prices of biotech drugs could be reduced if they faced competition from biosimilars, also known as follow-on biologics.

“If Congress creates an efficient pathway to follow-on biologic drugs and, at least as important, ends ‘pay-for-delay’ pharmaceutical settlements that delay generic entry, it will be taking a major step forward for both healthcare reform and affordable drugs for all Americans,” FTC chairman Jon Leibowitz said in a statement.

The commission said that competition between pioneer and follow-on biologics would not likely be similar to competition between branded and generic drugs because of the costs to obtain FDA approval and develop manufacturing facilities would limit the number of biosimilar manufacturers. The lack of automatic substitution between a pioneer biologic and a biosimilar would also likely slow the rate at which biosimilars could acquire market share, and they might have difficulty gaining market share due to concerns about safety and efficacy differences.

The report concluded that patent protection and market-based pricing would promote competition by biosimilars and spur biologic innovation, while legislation to create an abbreviated FDA approval process for biosimilars would likely be an efficient way to bring them to market because of the time and cost savings.

“Today’s report from the FTC is yet another endorsement of the need to move forward on passage of legislation that brings affordable biogenerics to patients sooner rather than later,” Generic Pharmaceutical Association president and CEO Kathleen Jaeger said. “FTC clearly stated that providing the Food and Drug Administration with the authority to approve biogenerics would be ‘an efficient way to bring these lower-priced drugs to market.’”

Jaeger noted that generic and branded drug companies alike — including Teva, Sandoz, Mylan, Merck & Co. and Pfizer — have expressed interest in developing biosimilars. Teva and Sandoz already make biosimilars for the European market, and Sandoz markets the biosimilar Omnitrope (somatropin) in the United States, though it had to undergo the same approval process as a pioneer biologic would to obtain FDA approval.

At the time of publication, the Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America had not released responses to the report.

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