Protecting America’s Leadership in Biotech Discovery

8/6/09

Health care reform took a turn for the better when members of key committees in both the U.S. Senate and House of Representatives recently recommended an approval pathway for biosimilars—products that attempt to be similar to an innovator biologic drug—while also preserving the hope for future medical treatments. Specifically, the committees agreed that to preserve medical innovation, biotech medicines should receive a reasonable 12 years of exclusive rights to their research data (also called “data exclusivity”) before a biosimilar may reference it for their own abbreviated approval. This period of time will act to preserve the research and development of breakthrough therapies for diseases like cancer, Alzheimer’s, and multiple sclerosis.

This is not simply a technical policy matter, but an important aspect of health care reform that is vital to the future development of new and better medicines. Amgen recognizes and supports a responsible, science-based regulatory pathway for biosimilars that ensures patient safety, follows sound science, demonstrates comparable efficacy — and as currently recognized by the Senate Health, Education, Labor and Pensions (HELP) Committee and House Energy and Commerce Committee — provides fair incentives for continued development of treatments for serious diseases.

We believe that a reasonable approval pathway for biosimilars will have a positive impact on our local and national economies. Washington state is a leader in biotechnology, and a biosimilar policy that preserves incentives for innovation will help ensure that our state can continue to be a leader in breakthrough medical innovation. Amgen is the largest private biotech employer in the region, providing approximately 900 jobs. The workforce we employ is highly educated, passionate about our mission to help patients, and dedicated to enriching the communities in which we live and work. Amgen’s Seattle-area laboratories are the largest commercial biotech facilities in the Pacific Northwest, representing a more than $600 million investment in biotechnology infrastructure.

The recent Senate and House committee decisions are also positive news for patients suffering from many types of crippling and life-threatening conditions who depend on the scientific breakthroughs that can only come from continued biotechnology research. As we frame changes to our health care policies, we must take care to preserve the innovation in biotechnology that holds the promise for future treatments for these patients.

Congress must also be mindful of the patient safety issues that are also at the heart of the biosimilars debate. It is essential that a scientifically-sound process is in place at the FDA to approve drugs that are similar, but not identical, to existing biotechnology medicines. Biologics are large, complex molecules, much larger and more complex than chemical molecules found in pills. You might visualize 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.

Jim Thomas, based at Amgen's Seattle facility, is vice president of research, process and product development. Follow @

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  • http://predict.net Cornelius

    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.