FDA biosimilar guidelines complete, waiting for publication

September 30, 2011 9:26 AM

According to very recent news, the most expected biosimilars guideline from US FDA might be published soon… 

United States has the biggest biopharmaceuticals market in the world and after big debates, earlier this year, the FDA has declared that, they would release the biosimilars guidelines by the end of 2011.

The latest news, which was published on PatentDocs.org yesterday*, shows us that, the eagerly awaited guideline might be published in the following days. According to a September 22 report by the biotechnology and pharmaceutical industry publication, BioCentury, which interviewed Janet Woodcock, the Director of the FDA Center for Drug Evaluation and Research, the FDA as it turns out recently completed the guidelines.

Additionally, Reuters reported last week that the deputy director of the FDA’s Europe office in London, Janice Soreth, told that the release of the biosimilar guidelines could come “as early as the next few weeks, maybe even days” .  Soreth pointed to last month’s New England Journal of Medicine article, 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 Sandoz, 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.


Source: www.patentdocs.org

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