Legal Research

This Week?s Biotech Highlights

By Jeremy Grushcow

I’m not sure whether it was the interception Peyton Manning threw last night, or my work earlier in the day trying to get my notebook to talk to my new router, but this week started looking like it was all about failed connections:

Pharmacy Benefits Managers (PBMs), pharmaceutical companies and government payors have all expressed a shared goal: getting ?the right treatment, to the right patient, the first time.?  Doing so would improve care (personalized medicine) and decrease costs (c0mparative effectiveness).  However, as industry players try to connect their employees, patients and customers with personalized treatments, they will sometimes be intercepted by the Genetic Information Nondiscrimation Act, other privacy legislation, or plain old public mistrust.

The EU has an established pathway for approving “biosimilars” — generic versions of complex biologic drugs, but with health reform stalled in the U.S., the biotech industry doesn’t know what will become of the biosimilars pathway that was set to be included in that legislation. 

But, as the week went by (despite being reuinted with my old router), I realized that for every Peyton Manning there is a Tracy Porter:

PBM giant Medco aims to overcome misunderstanding and mistrust with its purchase of DNA Direct this week.  DNA Direct uses its research on 2,000 available tests to help physicians, health insurance companies and patients understand how to use personalized medicine. 

Teva is a winner even with health reform stalled, since it filed a full biologics license application (BLA) for Neupoval last year.  The BLA asks the FDA to ignore the fact that Neupoval is a copy of Amgen’s already-approved drug Neupogen and treat Neupoval as if it was an entirely new drug.  This week, the FDA accepted Teva’s filing for review, allowing the company to proceed without needing new legislation (though Teva is still a long way from the plane of the goal line).

The moral of this week’s story is: “politically fragile biosimilars pathways are best ignored”… or “education is the key to personalized effectiveness”… or maybe “every cloud has a silver lining.”  Yep, that’s it.  So, stay tuned to the Cross-Border Biotech Blog for regular packets of optimism (even though they still mosey along at 54Mbps).

Full post as published by Slaw.ca on February 08, 2010 (boomark / email).