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Biotech / Medical : Biotech Valuation

CRSP 56.38

-9.0%

3:59 PM EST

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To: Icebrg who wrote (8977)	8/24/2003 12:50:45 PM
From: Biomaven	Read Replies (2) of 52153

<generic biologics> I think that getting approval via something analogous to an ANDA is not likely - it's simply too difficult to prove equivalence. But that doesn't mean you couldn't get approval via an independent trial - at least a large Phase I to show equivalent PK, but perhaps even something analogous to a later-stage trial. It's unclear to me whether these trials would have to wait for the patent expiration (on the small-molecule side, companies can do research leading to an ANDA even though the drug is still on patent). The point is that with a drug like EPO there are sufficient rewards that it would be OK to spend say $100m getting approval. I've never seen a discussion of approval via independent trials so basically I'm just speculating here. The patent estate surrounding biologics tends to be deeper and more complex than with small-molecule drugs, so I doubt if AMGN and the like will give in without a major battle. In terms of timing, I'd guess that we'll see a generic biologic this decade - say within a 4-7 year time frame. Peter

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