|FDA guidance on biosimilars may be imminent|
|By Staff and Wire Reports|
|Monday, 26 September 2011 04:41|
The FDA still plans to release the guidance by the end of the year but the agency's top drug official, Janet Woodcock, has indicated it could come "as early as the next few weeks, maybe even days," Janice Soreth, deputy director of the agency's Europe office in London, said on Friday.
Europe is ahead of the United States on this front, having already approved cheaper copies of some biotech medicines.The U.S. agency has completed work on the guidance and expects to release it "promptly," Woodcock said in an interview, according to the biotechnology trade publisher BioCentury. The agency has also reached a "tentative agreement" with industry representatives over user fees companies would pay to support the biosimilar approval process, according to minutes of a meeting between FDA and the industry posted on FDA's website.
Drugmakers, investors and others are eager to gain more insight for the approval process for cheaper versions of biotech drugs, known as "biosimilars" -- a potentially multibillion-dollar market.Soreth made her comments during a biosimilars panel at Windhover's Pharmaceutical Strategic Alliances Conference, held in New York.She said an article written by FDA officials in last month's New England Journal of Medicine was an indicator of what the guidance might look like. Agency officials said in the article that approval for biosimilars "will require a new paradigm of sponsor-FDA interactions," involving analysis of much more data than traditional generics.Unlike conventional, easy to replicate, chemical-based drug compounds, biotech drugs are derived from living organisms, such as proteins, and often produced using recombinant DNA technologies.Agreement on a pathway for producing cheaper versions of biotech drugs -- which treat diseases such as cancer, rheumatoid arthritis and multiple sclerosis -- has been far more difficult than for traditional pills and capsules because their complex manufacturing process does not lend itself to production of exact copies.
Making biotech copies is also expected to be more costly, as manufacturers must conduct extra clinical trials to show the new version is as good as the old one.Soreth said the FDA has received about two dozen meeting requests for proposed biosimilar products, involving potential versions of nine or 10 brand biotech drugs, or "reference"... Read More From Reuters' Lewis Krauskopf.
In early action on Monday, Stocks moved between slight gains and losses Monday after new home sales fell to a six-month low in the U.S. and investors remained concerned about Europe's debt crisis. Investors have been on edge about Europe's debt problems for months. Last week, the Dow Jones industrial average fell 6.4 percent. That was the biggest drop since the week ended Oct. 10, 2008, when it fell 18 percent at the height of the financial crisis.