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

To: scaram(o)uche who wrote (1969)	11/6/2000 1:47:42 PM
From: Biomaven	Read Replies (1) \| Respond to of 52153

Equivalency can be a tougher issue. A good example here (although not a biotech product) is Premarin, the near-billion dollar AHP drug extracted from cow urine. Generic competitors were denied "equivalence" because the AHP drug contained what most disinterested observers agreed were extraneous proteins that weren't also in the generic. This has been in dispute for years, so maybe it's been resolved by now. Another hormone, Synthroid, also put up a huge fight against generics. Peter

To: scaram(o)uche who wrote (1969)	11/6/2000 6:48:22 PM
From: Pseudo Biologist	Respond to of 52153

On the general topic of generic biologicals, Rick says Equivalency can be a tougher issue Yes, tough, as in there is no policy in the US right now other than doing your own trials. Two links: (1) Generic office for CDER (no such thing for CBER, yet) fda.gov Key point The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness (2) a ~1-year old article from Biospace: biospace.com Some quotes: Yet Jim Flynn, a pharmaceutical analyst at WG Baring Furman Selz (New York), sounds a clarion call of caution, stating that "no regulations have been developed yet for generic biopharmaceuticals. So not only is it unclear what the regulations will be, it's unclear whether those regulations will even allow a generic-biopharmaceutical market to exist." ... "With biopharmaceuticals, because of the complexity of the molecules, we can't accept bioequivalency, not in lieu of clinical safety and efficacy data," states Jay Siegel, the director of the Office of Therapeutics Research and Review at the FDA's CBER. And Harold Rode, a senior biologist in the Therapeutic Products Program at HC's Bureau of Biologics and Radiopharmaceuticals, adds that "concerning biopharmaceuticals, we don't believe in bioequivalency, at least not at this time." but OTOH: That a change is in the air is also the belief of Bank America Securities' Treppel. He says that Senator Orrin Hatch (R-UT), of the Waxman-Hatch Act, plans to convene a meeting between generic companies and brand-name companies, as well as their respective trade associations, and that generic biopharmaceuticals are "at the top of the agenda. You see, Hatch doesn't believe that biopharmaceuticals are entitled to the indefinite monopolies that they currently enjoy simply because there's no regulatory process in place to bring generic biopharmaceuticals to market. Hatch will make sure that the FDA begins to move such a regulatory process forward, because the FDA will only move such a process forward when someone in Congress tells them to move it forward." Teva's Barrett couldn't agree more, stating, "From a public-policy standpoint, there's no reason why, because a molecule is hard to make, it should have a life-long monopoly." PB, or as Rick says yech!