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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Sam Citron who wrote (9754)	12/13/2003 3:21:09 PM
From: software salesperson	Respond to of 52153

Reuters U.S. FDA chief eyes path for copycat biotech drugs Friday December 12, 4:18 pm ET By Ransdell Pierson WASHINGTON, Dec 12 (Reuters) - Food and Drug Administration (News - Websites) Commissioner Mark McClellan said on Friday it may be justifiable for regulators to approve generic forms of biotech drugs even if they have not been through the same lengthy clinical trials required of the original drugs. McClellan said the FDA is studying whether it has authority under federal law to approve generic versions of biotech drugs, such as human growth hormone and laboratory-altered insulin, once their original patents expire. The agency plans soon to unveil its thoughts on the issue and will also seek public comment on whether copycat biotech drugs should be approved, and under what conditions, he said. "We definitely will have more to say on this in the coming months because this is an important issue from the standpoint of innovation and affordability of safe drugs," McClellan told a luncheon with Reuters reporters. Biotech drugs are typically laboratory-altered forms of naturally occurring proteins, which are given by injection or intravenous infusion. They are difficult and expensive to make, and similar versions of the same protein made by different companies can have subtle differences. The FDA, by contrast, has for years approved copycat versions of standard synthetic "small molecule" drugs, which typically come in pill form. Patents on the oldest biotech drugs, including human growth hormone and laboratory-altered insulin, begin lapsing in the next few years and generic drugmakers are clamoring for the right to then sell their own cheaper copycat forms. Generic drugmakers say they are willing to conduct small trials to verify their products are safe, effective and have the same physical traits as original branded medicines, but claim they should not have to duplicate the lengthy and costly trials conducted by the original drugmaker. McClellan showed sympathy for that argument, but also said generic biologics should be evaluated individually, depending on the complexity of the particular protein. "I don't know that there will be any one general answer that will be applicable to all products. Some biologics are more complex than others ... I don't think there will be a universal answer," he said. "Published (studies) suggest, at least in some cases, that full-blown demonstration of effectiveness and toxicity may not be necessary," McClellan said. He said the safety and effectiveness of generic biotech drugs, in principle, could be judged instead by "short-term measures of how the product is working." For instance, he said companies now selling human growth hormone had to test their products for years in children to see results. "But if a new (generic) product had some shorter-term impact on a clinical measure -- on short-term growth -- that could potentially be an important factor in an approval," McClellan said.