Scott Reid, speaking for CVS Caremark Corp., suggested that even the name of the original be used for the biosimilar. Lot numbers could be used to track side effects, he said.

Others speaking for the pharmaceutical industry also urged more latitude in testing requirements.

“Solid clinical evidence” is needed before the FDA approves a drug as biosimilar, but “unnecessary clinical trials” would increase the economic burden, said Rivka Riven-Kreitman, a representative of Teva North America, which has been focusing on biosimilars production.

Jay Siegel, MD, head of regulatory affairs for Johnson & Johnson, told the panel, “Clinical outcomes measurements may not always be necessary.” In some cases, existing studies could be used to extrapolate a new drug’s effects, he said, including research of the 20 or more biosimilars that are already approved for use in Europe.  

“No Substitute for Testing”

But Gregory Schimizzi, MD, a rheumatologist speaking for the Coalition of State Rheumatology Organizations, said biosimilars may act differently in the body than the biologics upon which they are based, causing different side effects. The FDA should require clinical trials for all new products, regardless of their similarity to already-approved drugs, he argued. “[A] minor difference can cause a biosimilar protein to have vastly different effects. There simply is no substitute for testing these products given their complexity.”

The Foundation’s Wyatt added, “There will be subtle product variations that can have severe consequences.”

In addition, a surveillance system is critical for tracking adverse reactions to biosimilars once they come to market, said Wyatt. Patients have to be able to report side effects accurately to help ensure public safety.

Making these drugs affordable so more people can benefit from them is critical, but not at the risk of their health and safety, Wyatt argued.

“People will not trade a less favorable risk-benefit profile for a cheaper drug,” she said.  “That is simply unacceptable.”

The FDA will accept written comments through the end of the year at www.regulations.gov. Include the docket number: FDA–2010–N–0477.
Reporting by Larry Lindner