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March 08, 2010



More deja vu. I suspect this piece also didn't discuss the "safety" concerns with follow-on biologics. Or Europe's tragic experience with pure red cell aplasia involving erythropoietin (EPO). Or even more relevant, that follow-on biologics currently must undergo the same approval process that the pioneer biologic underwent.

With follow-on biologics, the media again asks Americans to buy into a sense of "entitlement." What happened to America as the "land of opportunity?" As I've said before, journalism as we once knew it in America is dead.

Kevin, your "cold-blooded" summation is right on. Why would any individual (or venture capitalist) invest in something that has such a high risk with little reward. Two other key points from Henry Grabowski's paper: 1) Biologics have higher overall success rates than chemical drugs but lower success rates in the most expensive Phase III trials. In other words, they incur high development costs pre-failure. 2) Companies needs to maintain a large portfolio of products because very few products actually become "blockbusters." Obviously, it's expensive to maintain this portfolio but there is no Magic 8 Ball to predict the eventual winner(s). If the exclusivity period is too short (or non-existent), these companies will have little opportunity to make a profit which will drive away investors. Without investors there will be few new biologic innovations. Can we really afford that cost?

If this topic interests your readers, several senior principals in Fish & Richardson's life sciences group will be discussing legal strategies for discovering and developing new pharmaceuticals at the upcoming Patent Resources Group presentation, "Pharma & Biotech Strategies for Patent Prosecution, Hatch-Waxman, and Litigation." For information about this (and 18 other advanced law topics, being presented in Bonita Springs, Florida in April), visit http://www.patentresources.com/programs.aspx?program=49

What is the average salary of a Big Pharma CEO?

Thank you for pointing out several of the inaccurate statements in the recent NYT guest editorial. Biotechnology Industry Organization (BIO) President & CEO Jim Greenwood wrote a blog bost on how misinformation, including the misleading and blatantly false statements in the NYT guest editorial, is an impediment to an informed public dialogue on biosimilars. It is available on BIO's website at http://www.biotech-now.org/2010/03/15/countering-misinformation-biosimilars.

Professor Henry Grabowski is a knowledgeable guy, and a nice person. He is also a long time consultant to the drug companies, and hardly a disinterested expert on this issue. At this point in time, there is almost no relationship between the regulatory barriers to competition and the actual investments that companies make. At some point in the march toward bankruptcy of the health system, people need to think about how we are spending our money, and how efficient are all of these non-patent incentive programs.

Dear James:

"At this point in time, there is almost no relationship between the regulatory barriers to competition and the actual investments that companies make."

I assume you have evidence for this statement. Care to provide us with any?

Thanks for the comment.

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