Monday, May 19, 2014

A Few Thoughts About Biosimilars

I have more than a few thoughts about biosimilars, but will provide a more extensive version of my views at a later date. For now, I would like to point to two significant new developments in the biosimilars field, both in the news this week. In the first, the FDA released a Draft Guidance that provides more details of the Agency's approach to the nitty gritty of the clinical testing of investigational biosimilar products.1 In the second major biosimilar news of the week, Samsung (yes, Samsung the Korean electronics giant) announced that it is committing at least $2 billion dollars to developing biopharmaceuticals through two separate efforts. In one venture, "Samsung Bioepis" is  partnering with Biogen Idec to develop biopharmaceuticals including biosimilar versions of Roche's Herceptin anti-cancer antibody as well Sanofi's Lantus diabetes drug.2 In Samsung's other biologics effort, Samsung Biologics will work with Quintiles, the global contract research organization (CRO), to develop biologics for Roche and Bristol Meyers Squibb. I believe that taken together these two events, the FDA's emerging regulatory requirements and Samsung's commitment to biologics and particularly biosimilars, underscore the two very different kinds of risk that confront entrants into the biosimilars field. The first risk, which is reflected in the FDA's Draft Guidance, is the scientific/regulatory risk that is entirely a function of the developing science of protein production and analysis. The second risk, which is reflected in Samsung's partnerships with Biogen Idec, Roche, and Bristol Meyers Squibb, is the market risk, which is a function of the difficulties of competing both against the original "reference" biologic as well as the other entrants into the biosimilars field. I am willing to stick my neck out on this issue and say that, in my view, it is this second risk that is more significant.

Saturday, May 10, 2014

Ethics, Bioethics, and Biomedical Research

Two stories in the past two weeks, one on the therapeutic cloning of human stem cells,1 and the other on the successful replication of DNA containing two new, non-naturally occurring synthetic DNA bases in a cell2 have prompted me to turn to the subject of bioethics.  I have been studying and writing about biotechnology since 1984 and for quite a while people would conflate biotechnology with bioethics. When I would tell people that my area of law was focused on biotechnology, I would frequently get the response, "like designer babies?"   I would respond, "No, that's a bioethics issue, and I rarely do anything ethical."  My joking response was intended to emphasize the distinction between biotechnology, which is simply the use of modern molecular biology as a tool in a variety of areas, from bioethics, which is the effort to analyze issues concerning human life and health in ethical terms. In the 1980's and much of the '90's,  my response was true. The biotechnology industry was focused on healthcare innovation and faced numerous issues concerning intellectual property rights and federal regulation. Very few, if any, of the issues faced by the developing biotechnology industry raised new or difficult ethical issues.  Companies were (and are) trying to develop human therapeutics and diagnostics and the ethical issues were much the same as had faced the pharmaceutical and medical device industry for decades: informed consent; ensuring that clinical trials provided a sufficient potential for good to justify human experimentation; and, providing access to lifesaving drugs in less developed regions of the world. Then, in 1998, James Thompson and others at the University of Wisconsin reported that they had successfully isolated and cultured human embryonic stem cells.3 With that step, some of what biotechnology researchers and companies were attempting to do became embroiled in ethical controversy. Soon afterwards, in 2001, the Human Genome Project announced the completion of the first draft of the complete human genome. Issues of genetic testing and genetic discrimination, which had been simmering for some time, became much more imminent. I could no longer make my joke, as embryonic stem cells and genetic testing were no joking matter and could not be ignored.

FiercePharma: 10 big brands keep pumping out big bucks, with a little help from price hikes

Tracy Staton, writing for FiercePharma, provides a very interesting analysis of ten drugs that somehow keep sales up and prices rising despite challenges from competitive drugs, patent expirations and safety issues.

Sunday, May 4, 2014

A Brief Comment on Patents and Particularly Pharmacogenomics and Personalized Medicine

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To begin this discussion of patents in pharmaceutical policy, let me first set out two basic points that I think are central to pharmaceutical policy. First, I believe that strong patent protection, at least in developed countries, is an essential component of pharmaceutical policy. Second, I believe that the rapid development and implementation of pharmacogenomics and personalized medicine are absolutely critical for pharmaceutical policy. However, I do not necessarily believe that the development and implementation of pharmacogenomics and personalized medicine require the same breadth of patent protection afforded to the development of new drugs. Patent protection, and with it the rewards of the exclusive rights to make, use, or sell the patented invention, has been a feature of the legal landscape in every country in which significant numbers of new drugs have been developed since the modern pharmaceutical industry began. There have been proposals to do away with patents.  Prizes seem to be a recurrent suggested alternative to patents.1  However, I think it is clear that prizes are not a viable alternative reward for the occasional success in a risky and expensive enterprise. No one suggests prizes on the scale of the profits that are earned through patent protection when that risky and expensive enterprise succeeds.  It is simply not logical that the amounts of capital required to drive pharmaceutical innovation and drug development would be invested under a prize system, or any other system which significantly reduces the rewards obtainable with strong patent protection. However, that is not to say the details of the current system get the balance right. A number of years ago I suggested that much broader patents should be awarded for the significant innovation that is accomplished by the discovery and validation of a new target for drug development.2 While the Court of Appeals for the Federal Circuit (the principal forum for patent law in the U.S. other than the Supreme Court) has moved further in the other direction (over the vigorous dissent of Judge Rader),3 I still believe in the core of that argument and will expand on that problem in a future post. For now, it is sufficient to say that the validation of new biological targets for pharmaceutical therapy are the biggest (and riskiest) innovations in the drug development enterprise. Ideally the patent system would provide financial rewards that are proportional to the degree of innovation. That is not the system we have, but it is a reasonable and reasonably obtainable goal.