Replies to post #5180 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

FoB update – Europe’s CHMP approved another biosimilar yesterday: an Epogen knockoff from Stada that will be marketed in most EU countries by Hospira (the spin-off from ABT).

http://biz.yahoo.com/prnews/071019/aqf038.html?.v=22

[DewDiligence]

GTC’s Role in Follow-On Biologics

[Rewritten with lots of new material on the
economic and political impetus for FoB’s.]


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.

An FoB must be close in structure and function to an approved drug, which allows regulators to short-circuit the FoB approval process to some degree. In other words, approval of an FoB is based, at least in part, on the established clinical data for the already-approved drug that the FoB is similar to.

FoB’s are an avenue for GTC to leverage its proprietary production platform. For an FoB, the surest way to capture 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.

--
Does the US have a regulatory pathway for FoB’s?

No, not yet. In 2007, a US Senate committee endorsed an FoB bill (#msg-20694180) but, alas, the US House did not follow suit (#msg-22653513).

Despite the speed bumps, nearly all industry experts agree that US legislation to enable FoB’s is a matter of when, not if, and “when” is apt to be soon. The reason: the US healthcare system can’t afford not to have FoB’s. Read this article on the state of the Medicare system and you’ll quickly see why: #msg-19589981. Here’s a brief excerpt:


“On the supply side, the way health care is produced
must fundamentally be changed, replacing cost-
increasing innovations with cost-reducing ones.”


FoB’s in general—and GTC’s platform in particular—is a way to reduce healthcare costs.

Still not convinced? Read this: #msg-19600197.

Too lazy too read these articles? No problem—just scan this chart, which shows most of what you need to know: #msg-23009572.

Obviously, the status quo is unsustainable. Moreover, the arguments that have been promulgated against FoB’s by Big Biotech do not hold water (#msg-20359323).

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

Follow the money and the patent expirations:

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

--
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 miscellaneous references on FoB’s:

#msg-11358021 FDA approves Omnitrope
#msg-20668311 FoB approvals in the EU
#msg-23821896 Ditto
http://www.followonproteins.com/ New FoB website
#msg-5251149 Old article from Technology Review is still a good read