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DewDiligence

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DewDiligence

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Re: None

Thursday, 07/05/2007 2:44:35 AM

Thursday, July 05, 2007 2:44:35 AM

Post# of 19309
GTC’s Role in Follow-On Biologics

The term follow-on-biologic (FoB) has come into vogue as a descriptor for a protein drug that is similar to an already-approved drug. Other terms that are used are biogeneric and biosimilar.

FoB’s are an avenue for GTC to leverage its proprietary production platform. By definition, an FoB is similar to another drug and hence it can’t readily be differentiated based on characteristics of the drug itself (but see info below on ADCC). Hence, the surest way to capture significant market share and still realize a robust profit margin is to have rock-bottom production costs. This can be accomplished in two main ways: i) by producing in a low-cost region; or ii) by employing a low-cost production technology.

Companies such as Teva, Novartis/Sandoz, Barr (Pliva), and Mylan (Merck KGaA) are pursuing the former path; companies such as GTC, SemBioSys, and Biolex are pursuing the latter.

--
Which branded drugs are the best candidates for a FoB?

Follow the money! This post shows the largest classes of biopharmaceuticals by worldwide 2006 sales:

#msg-20699044

--
What about the regulatory climate for FoB’s?

#msg-20694180 Pending U.S. legislation
#msg-20359323 Objections of Big Biotech don’t hold water (IMO)
#msg-11358021 FDA approves Omnitrope
#msg-20668311 Latest FoB approvals in the EU

--
Are there any technical advantages that GTC’s FoB’s might provide relative to their branded counterparts?

Maybe. One such advantage might be enhanced Antibody-Dependent Cellular Cytotoxicity (ADCC). GTC mentioned ADCC prominently on the 4Q06 CC (#msg-17607391, scan about halfway down). More recently, ADCC made news implicitly when Amgen’s Vectibix failed to receive EU approval (#msg-19999027).

--
Finally, here are some general references about FoB’s:

http://www.followonproteins.com/ New FoB website
#msg-5251149 Old article from MIT’s Technology Review still a good read

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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