FDA Biosimilar Guidance May Be Here In ‘Days’

FDA Biosimilar Guidance May Be Here In ‘Days’

September 26th, 2011 // 12:02 pm @ jmpickett

The long-awaited arrival of the FDA guidance for biosimilars may be imminent, at least according to one agency official. Although the FDA plans to release the document by the end of the year, Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Researcy, has indicated the guidance may be “as early as the next few weeks, maybe even days,” according to another agency official.

The forecast was made by Janice Soreth, deputy director of the FDA’s Europe office, which is in London, on a panel about biosimilars at the Windhover Pharmaceutical Strategic Alliances Conference in New York, according to Reuters. Meanwhile, Woodcock separately told BioCentury that the agency has finished work on the guidance and its release is expected “promptly.”

The agency has also reached a “tentative agreement” with the pharmaceutical industry over user fees that drugmakers would pay to support the biosimilar approval process, according to minutes of a meeting between FDA and the industry posted on FDA’s website, Reuters adds..

This is one of the most eagerly awaited documents from the FDA. A wide array of groups – drugmakers, investors and payers, among others – have been clamoring for details about the approval process that would be required to bring lower-cost versions of expensive biologics to patients. The advent of these biosimilars is forecast to eventually become a multi-billion-dollar market.

Biosimilars, which would largely be injectable products, are already available in Europe. But reaching agreement on a so-called pathway for making biosimilars has been an arduous process because these medications are much more difficult to make than pills and capsules because of a complex manufacturing process that may not yield exact copies, Reuters notes.

However, Soreth noted that an article written by FDA officials last month in The New England Journal of Medicine provided some insight into the pathway. In that article, Woodcock and others wrote that approval “will require a new paradigm of sponsor-FDA interactions,” involving analysis of much more data than is required to make traditional generics (here is the article).

Initially, this process may not allow such direct substitutions or involve steep pricing discounts. In fact, the panelists at the PSA conference agreed that discounts, so far, have ranged from about 20 percent to 40 percent. Soreth said the FDA has received about two dozen meeting requests for proposed biosimilars, involving potential versions of nine or 10 brand biotech drugs.

Michael Kamarck, president of Merck BioVentures, said the experience in Europe demonstrated the products will require conventional marketing and outreach support. Doctors and patients, he added, may demand more evidence beyond FDA approval. “In small molecule generics, you get these products licensed and registered and you’re done. It’s just the beginning for these products,” he told the crowd. “We are assuming this is a branded business for the next at least four or five years.”

But Jim Roach, chief medical officer of Momenta Pharmaceuticals, said the pressure brought by payers and to lower drug costs may ultimately prompt increased use of biosimilars. “That pressure will only continue to increase over time,” he said. “To the extent you can convince regulators that your product is highly similar and perhaps indistinguishable and potentially interchangeable, I think the products will be taken up quite well.”

Source: Pharmalot