By James DeGiulio --
Earlier this year, the U.S. Food and Drug Administration declared that it would release regulatory guidelines for biosimilars by the end of 2011, and since the FDA's announcement, the biotechnology industry has eagerly awaited the agency's insight on gaining approval for biosimilars in a potentially multi-billion dollar U.S. market. Just last month, the FDA seemed to be a ways off from promulgating guidelines, continuing to struggle with many of the issues involved with these complex biological products. However, according to a September 22 report by the biotechnology and pharmaceutical industry publication, BioCentury, which interviewed Janet Woodcock (at right), the Director of the FDA Center for Drug Evaluation and Research, the FDA as it turns out recently completed the guidelines.
In addition, Reuters reported last week that the deputy director of the FDA's Europe office in London, Janice Soreth, told attendees at Windhover's Pharmaceutical Strategic Alliances Conference that the release of the biosimilar guidelines could come "as early as the next few weeks, maybe even days" ("U.S. FDA guidance on biosimilars may be imminent"). Soreth pointed to last month's New England Journal of Medicine article (see "FDA Looks to Multiple Sources, Including EMA Guidelines, in Developing Biosimilar Approval Standards"), written by FDA officials, as an indicator of what the guidance might look like. Soreth said the FDA has received about two dozen meeting requests for proposed biosimilar products, involving potential versions of nine or ten reference products. The biosimilars panel included traditional generic drugmakers, such as Novartis' Sandoz division, as well as brand pharmaceutical companies like Pfizer and Merck, suggesting that industry players on both sides of the field will be involved in biosimilars. Many predict that the industry will see companies abandon their typical roles, switching sides from "brand" to "generic," and vice versa (although the term "generic" should not be used to describe a "biosimilar").
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