Protecting America’s Leadership in Biotech Discovery


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the difference by thinking of a jigsaw puzzle. A small molecule drug could be represented as one simple piece of that puzzle, but a biologic would be made up of hundreds or perhaps thousands of puzzle pieces, fitted together in a precise way to make a picture of the Mona Lisa. If some of the pieces were missing or arranged a little differently, it would not be identical to the actual picture. By analogy, the critical scientific issue is whether differences between the innovator drug and biosimilars influence safety or efficacy. While it is possible to synthetically manufacture an exact copy of a relatively simple drug used in a pill, it is virtually impossible to manufacture an exact copy of a complex biologic made by a living organism.

At Amgen, I oversee the function that takes promising large molecules from research and determines if they can be manufactured and formulated safely and efficiently. I know firsthand the complex challenges of taking a therapy from discovery, through process science, clinical manufacturing, clinical trials and finally to market approval. Doing this in a highly regulated environment, with a focus on the health and safety of patients make this one of the most complex businesses on the planet. Bringing one new biologic drug through this entire journey can take 10 to 15 years and costs approximately $1.2 billion. These are real numbers and the current cost of new therapies. Through their recent action, the Senate and House committees have recognized that innovators should have a reasonable amount of time to recoup the substantial investment required to bring medicines to patients and to fund new drug development.

Despite the challenges, biotechnology is finally delivering on its promise to deliver important therapeutics to treat serious diseases such as leukemia, cancer, diabetes, rheumatoid arthritis and multiple sclerosis. Through the hard work and innovation of an army of dedicated scientists, many biologics are now available to the patients who need them. Our strong university systems and entrepreneurial spirit in the US birthed this important medical industry. In many respects this industry is a reflection of some of the best that our country can deliver, but to remain a world leader in biotechnology, we must continue to reward innovation.

Let’s make sure we sustain our ability to innovate by supporting the 12-year data protection period, making this a win for both patients and our economy as it becomes part of our national health care policy for the 21st century.

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One response to “Protecting America’s Leadership in Biotech Discovery”

  1. Cornelius says:

    Amgen has not invented a drug in years- they bought all their pipeline. Thus they cannot speak on biotech innovation. They just want to protect their monopoly.
    The author conveniently does not say that Amgens original drugs have mutations from batch to batch, and indeed the original drug
    that got approved is not exactly the same as is what is sold today. However, they have the same efficacy and side-effect profile, and that is what matters. Thus a biogeneric will be just as good as the original. He also neglects to mention that it takes LESS time to bring a biologic to market- they are usually for niche indications, later expanded, that go under the orphan drug act, allowing compassionate use, faster approval times, etc. Finally, 5 years exclusivity has provided plenty of incentive for small molecules companies to innovate- if you want to increase such innovation find a path for the biotech IPO market to innovate. That will provide plenty of motivation, and more importantly cash, to start new companies.