GTC Biotherapeutics (fka GTCB)

[DewDiligence]

GTC’s Role in Follow-On Biologics

[Added entry re GENZ’s Myozyme.]


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 Novartis, Teva, Barr, and Mylan are pursuing the former path; companies such as GTC, SemBioSys, and Biolex are pursuing the latter.

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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 it 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 #msg-19600197 and #msg-27114485.

Too lazy too read these articles? No problem—just examine the chart at the top of #msg-27114485, which shows most of what you need to know. And don’t forget that the numbers in the latest government forecasts are worse than the numbers in this chart!

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).

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Which branded drugs are the best candidates for a FoB?

Follow the money and the patent expirations:

#msg-20699044 Largest classes of biopharmaceuticals
#msg-23016754 Patent-expiration dates for selected biopharmaceuticals

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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 2007 annual shareholders' meeting. Moreover, GTC has a patent application on the production of antibodies with enhanced ADCC (#msg-20219243).

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Here are some miscellaneous references on FoB’s:

#msg-11358021 FDA approves Omnitrope
#msg-20668311 EU approves EPO FoB’s
#msg-26999717 EU approves G-CSF FoB’s
#msg-28707403 Musings on Myozyme
http://www.followonproteins.com/ New FoB website
#msg-5251149 Old article from Technology Review is still a good read