FDA guidance on biosimilars may be imminent Print E-mail
By Staff and Wire Reports   
Monday, 26 September 2011 04:41
The U.S. Food and Drug Administration appears to be on the verge of issuing long-awaiting guidelines for the development of generic versions of complex biotechnology medicines.

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. 

In the Healthcare sector, MELA Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued an Approvable Letter for the MelaFind Pre-Market Approval (PMA) application. The Company intends to work with the agency to finalize the physician and patient labeling, package insert, user's guide, training program and clinical protocol for a post-approval study in order to obtain final approval. Early this month, ther firm announced that it received CE Mark approval for MelaFind, allowing the Company to market its MelaFind device to dermatologists across the European Union (EU). Shares are leading the pack of healthcare stocks and traded as high as $6.20 this morning.

Here are the movers in healthcare in at mid-day on Monday:

Gainers (% price change) Last Trade Change Mkt Cap
MELA Sciences, Inc. MELA 5.10 +1.92 (60.38%) 128.84M
Delcath Systems, Inc. DCTH 3.72 +0.31 (9.09%) 178.54M
ImmunoGen, Inc. IMGN 11.09 +0.83 (8.09%) 847.04M
NuVasive, Inc. NUVA 20.06 +1.02 (5.36%) 800.00M
Affymetrix, Inc. AFFX 5.01 +0.24 (5.14%) 352.89M
Losers (% price change)
United Therapeutics Corp. UTHR 38.52 -2.19 (-5.38%) 2.25B
Skilled Healthcare Group SKH 3.47 -0.19 (-5.19%) 131.93M
Geron Corporation GERN 2.15 -0.08 (-3.59%) 277.33M
Vertex Pharmaceuticals VRTX 49.00 -1.73 (-3.42%) 10.20B
Kindred Healthcare, Inc. KND 9.21 -0.32 (-3.36%) 479.96M
Most Actives (dollar volume)
Johnson & Johnson JNJ 62.63 +1.04 (1.69%) 171.63B
Pfizer Inc. PFE 17.55 +0.10 (0.57%) 136.93B
Merck & Co., Inc. MRK 31.56 +0.51 (1.64%) 97.23B
Gilead Sciences, Inc. GILD 39.71 +1.28 (3.33%) 30.63B
Abbott Laboratories ABT 50.64 -0.32 (-0.63%) 78.83B

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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