Congress must preserve patient safety, innovation in regulating 'biosimilars'

AS President Obama and Congress work to enact a comprehensive health-care plan, it is important to understand the consequences of proposed legislation on biosimilars. These proposals would regulate the process for federal approval of drugs similar, but not identical, to existing biotechnology medicines or "biologics."

Unlike generic drugs, which are chemically identical to name-brand pills, biologics are large, complex molecules made by living cells and are impossible to copy exactly. The term "biosimilar" denotes the copies are similar, not identical. This important distinction should be carefully considered as a pathway for biosimilars is developed.

Amgen currently has eight marketed products, seven of which are biologic therapies including Enbrel, which is approved to treat moderate-to-severe rheumatoid arthritis and certain other inflammatory diseases. The company has long supported a responsible, science-based regulatory pathway for biosimilars that ensures patient safety, follows sound science, demonstrates comparable efficacy, and provides fair incentives for continued development of treatments for serious diseases.

House Bill 1548, sponsored by Reps. Anna Eshoo, D-Calif., Joe Barton, R-Texas, and Jay Inslee, D-Wash, as well as the compromise legislation under consideration in the Senate, provides a rational path forward for biosimilars that protects patient safety through clinical trials and maintains appropriate incentives for the development of innovative therapies for the many diseases without a treatment or cure.

As a physician, I cannot emphasize enough how vital clinical trials are for patient safety. Subtle differences in the cells or manufacturing processes used for producing biologics can result in differences in efficacy or safety risks. Biosimilars should be required to undergo clinical trials to demonstrate their safety and effectiveness before they are released. Documented cases illustrate the serious, even life-threatening, immune response that may arise because of manufacturing processes that are similar, but not identical, to the original therapy. Many patient and physician organizations also support HB 1548. There are no shortcuts when it comes to safety.

Biosimilar legislation must also protect further development of groundbreaking treatments for serious diseases. As a medical resident I was often frustrated with the limitations of current treatments; and doctors continue to be hampered by a lack of medicines for many serious and debilitating conditions. This experience was the catalyst that changed the course of my career from a physician treating individual patients, to a medical researcher hoping to help millions of patients through the development of new therapies.

A responsible path to biosimilars is not a barrier to competition. Indeed, there are already many competing biotechnology medicines. The bedrock for fair competition is legislation that supports the same high standards for all new medicines and protects the entrepreneurship and innovation thriving in labs across America.

Congress must protect the data and intellectual property of innovator organizations by recognizing existing constitutional and statutory patent rights. Delivering a new medicine from discovery to patients is a 10- to 20-year journey with an average investment of $1.2 billion. Amgen and other organizations that have made commitments to advancing health must be allowed a reasonable amount of time to recoup this substantial investment and ensure the continued innovation required to bring new medicine to patients.

Today we are at a crossroads in our efforts to contain costs of not only medicine, but the collective health-care elements, from hospitalizations, to medical records, to insurance premiums; but we must not overlook the long-term advances to the treatment of serious illnesses that science can deliver.

There is a place for biosimilars in health-care reform, but it must be one that protects the safety of our patients and that does not stall the progress of research that holds the promise of better treatments.