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Biotech / Medical : Biotech Valuation
CRSP 56.38-9.0%Nov 4 3:59 PM EST
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To: Harold Engstrom who wrote (8976)8/23/2003 10:59:53 AM
From: Icebrg  Read Replies (1) of 52153
 
re: generic biologics

>>A case in point is rebif: same molecule as avonex, but the FDA would not allow Serono to use Biogen's data.>>

Another case was XANELIM where FDA requested a further study to confirm that equivalence. If I remember correctly the study used material produced by XOMA to start with and later switched to material sourced from Genentech. In this connection there were also some minor modifications done to the process.

During Phase III Xanelim testing, minor manufacturing modifications were made to allow for large-scale material production. These modifications were discussed with and agreed to by the FDA. Recently the agency requested that a pharmacokinetic study be completed to confirm head-to-head equivalence between the Xanelim material used for clinical testing and the Xanelim material planned for large-scale manufacturing. Genentech and XOMA will initiate this study shortly and anticipate filing the BLA pending successful study completion.

If even DNA and XOMA had problems to convince FDA that the material was bioequivalent despite the fact that they were both working towards this goal, how difficult will it not be for a generic manufacturer to achieve this without any support whatsoever from the original manufacturer.

Erik
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