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DewDiligence

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DewDiligence

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Re: DewDiligence post# 5030

Friday, 10/12/2007 4:12:36 PM

Friday, October 12, 2007 4:12:36 PM

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

[Added table of patent-expiration dates
for big-selling biopharmaceuticals.]


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: 1) by producing in a low-cost region; or 2) 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?

#msg-20699044 Largest classes of biopharmaceuticals
#msg-23029249 Patent-expiration dates for selected biopharmaceuticals

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

#msg-20694180 Senate committee endorses FoB bill
#msg-22653513 But, alas, the House has not
#msg-20359323 FoB objections from Big Biotech don’t hold water
#msg-11358021 FDA approves Omnitrope
#msg-20668311 Latest FoB approvals in the EU

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

One such advantage might be enhanced antibody-dependent cellular cytotoxicity (ADCC). Dr. Cox mentioned ADCC prominently in #msg-17607391 (scan about halfway down), and Dr. Meade talked about it at the annual shareholders' meeting.

Moreover, GTC has a patent application on the production of antibodies with enhanced ADCC (#msg-20219243).

--
Here are some general references on FoB’s:

http://www.followonproteins.com/ New FoB website
#msg-5251149 Old article from Technology Review is 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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