Statement of David Schenkein, M.D.

David Schenkein, M.D.
Vice President, Clinical Hematology/Oncology, Genentech

Entire written testimony available here. (PDF format)
On Behalf of the Biotechnology Industry Organization

Before the House Committee on Energy and Commerce,
Subcommittee on Health

Hearing on Assessing the Impact of a Safe and Equitable
Biosimilar Policy in the United States

MAY 2, 2007

Good morning, Mr. Chairman and Members of the Committee. My name is Dr. David Schenkein and I am vice president of Clinical Hematology and Oncology at Genentech. I have been a practicing oncologist for the past 20 years and I am pleased to come before you today on behalf of the Biotechnology Industry Organization.

Genentech is considered the founder of the biotechnology industry. We began 31 years ago with the goal of developing a new generation of therapeutics created from genetically engineered copies of naturally occurring molecules important in health and disease. Our mission is to end the death sentence that cancer currently represents by creating medicines that will transform cancer into either a curable illness or a chronic condition.

In order to ensure that innovative biotechnology products continue to reach patients and physicians, it is essential that Congress adopt six key principles in creating any regulatory pathway for follow-on biologics.

First and foremost, legislation must ensure patient safety. Patients should not have to accept greater risks or uncertainties in using a follow-on product than an innovator’s product. In addition, legislation must recognize that biologics are far more complex than small molecule chemical drugs. It must maintain the physician-patient relationship and allow only treating physicians to determine whether a follow-on product is interchangeable for the innovator product. It must preserve incentives for innovation, must ensure a transparent regulatory process, and must continue to prioritize the FDA’s review of new therapies and cures.

In oncology, we treat life threatening illnesses. For many patients, the first therapy is a chance for a cure that evaporates if the disease recurs, making it incurable – it is a critical window of opportunity.

Take for example the situation that women with Her2 positive breast cancer face every day. At diagnosis, women are treated with a balance of chemotherapy and the biologic Herceptin, along with surgery and radiation. For the majority of these women, in part because of the effectiveness of Herceptin, their cancer will not return. Imagine a situation where a woman is treated with a follow-on biologic in this setting that has even a slightly different profile, which allows her cancer to return years later. The disease has now spread and her chances of survival are reduced significantly. What do we tell that woman and her family? That we never tested that follow-on biologic in humans, but we thought it was similar enough to Herceptin and relied on those data to support its approval and to advocate for its use?

I firmly believe there will always be a need for clinical testing of a follow-on biologic. The amount and type of testing will depend on the specifics of the product and assessment of potential risks, and those determinations should be left to the FDA. Clinical trials will always be important to address questions such as immunogenicity. I would never take a biologic that had not been tested in humans; the risks are too high. New legislation should not cause others, who may be less informed, to do so.

In addition to scientific considerations, I would also like to address the importance of incentives. As an oncologist, I am extremely concerned about the potential that limited or no data exclusivity would have on adjuvant – or early-stage – cancer drug development. It is in this setting that we hope to translate breakthrough discoveries into cures. Insufficient data exclusivity could strangle the incentives to continue investing in trials beyond the advanced or metastatic stage.

Adjuvant studies are typically started only after positive Phase III trials in metastatic cancer, and are apt to return data late in the patent life of the product. Trials of adjuvant therapy are intended to catch the cancer at the time before it spreads, where our therapies could have the greatest impact for patients. The approval for Herceptin in the adjuvant setting occured 8 years after the original approval in the metastatic setting, and involved more than 3,500 women in multiple randomized clinical trials. These trials can take easily more than 5 years from inception to completion at huge cost, without any assurance of clinical success. Herceptin in the adjuvant setting reduced the risk of cancer recurrence by 50 percent – and if the cancer doesn’t recur, these women cannot die from it.

This is our mission – to beat cancer through science. But without a substantial period of data exclusivity, it would be difficult for Genentech and others to invest in this critical but costly research.

I am excited every day when I look at the pipeline we have at Genentech. We are developing biologics that starve tumors, cause cancer cells to self-destruct and “program” them to behave differently in the body. It is my hope, and that of BIO and Genentech, that a transparent public process that leverages known scientific considerations will provide a framework and pathway for the approval of follow-on biologics. The stakes are simply too high to risk patient safety and potential cures by moving too quickly and not following the science.

Again, I thank you for the opportunity to testify before you today, and look forward to answering any questions you may have.