About...
James Greenwood
James C. Greenwood is President and CEO of the Biotechnology Industry Organization (BIO) in Washington, D.C., which represents more than 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the annual BIO International Convention, the world's largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.
Mr. Greenwood represented Pennsylvania's Eighth District in the U.S. House of Representatives from January 1993 through January 2005. A senior member of the Energy and Commerce Committee, he was widely viewed as a leader on health care and the environment.
From 2001 to 2004, Mr. Greenwood served as Chairman of the Energy and Commerce Subcommittee on Oversight and Investigation with oversight authority over issues in the full Committee's vast jurisdiction. He led hard-hitting investigations into corporate governance at Enron, Global Crossing and WorldCom; terrorist threats to our nation's infrastructure; and waste and fraud in federal government agencies.
Prior to his election to Congress, Mr. Greenwood served six years in the Pennsylvania General Assembly (1981-86) and six years in the Pennsylvania Senate (1987-1992).
Biotechnology Industry Organization
Today, we have biotechnology to thank for therapies and medicines that treat debilitating diseases like cancer, HIV/AIDS, Alzheimer's and multiple sclerosis - and for promising next generation therapies still under development for these and other diseases. Expanding access to these biologic therapies is crucial. Medicines called "biosimilars" or "follow-on biologics" - that is, medicines that are similar to, but not the same as innovative biologic medicines - hold tremendous promise for increasing the availability of biologic medicines to patients.
Congress is currently considering legislation that would establish a legal and regulatory pathway for development of biosimilars. Done correctly, this could help increase access to these critical, breakthrough treatments and preserve our ability to harness science to tackle some of the toughest medical challenges in our time.
Some inaccurately suggest that biosimilars are essentially generic versions of traditional pharmaceutical drugs. Biologic medicines are made from living cells through a complex process, one far more exacting than the one used to manufacture traditional, chemical-based drugs like aspirin. Indeed, if making a conventional drug were like preparing Kool-Aid, then making a biologic would be like producing wine.
This means that, unlike replicating traditional pharmaceuticals, manufacturing an exact duplicate of an existing biologic is impossible with existing science. The inexact nature of the duplication process means that a biosimilar can have a markedly different impact than the original on a patient. For this reason, a responsible regulatory pathway should require that all biosimilars undergo their own rigorous clinical trials to guarantee their safety and effectiveness.
One legislative proposal, introduced by Reps. Anna Eshoo (D-CA), Jay Inslee (D-WA) and Joe Barton (R-TX), lays out an effective, reasonable and safe pathway for approval of biosimilars. Importantly, this bipartisan bill provides the right balance among safety, innovation and expanded competition. For example, the bill requires biosimilar manufacturers to provide the Food and Drug Administration (FDA) with clinical data on the safety and efficacy of their medicines, but also provides the FDA with the discretion to waive the requirement on a case by case basis. This provides the FDA with flexibility to determine the level of safety review required commensurate with the complexity and understanding of the biologic.
The bill also recognizes that that it is essential for doctors and patients (rather than pharmacists or health insurers) to decide whether an innovative medicine or biosimilar would be better for an individual patient. This falls in line with recommendations made by the American Academy of Pediatrics and the American Medical Association.
Unlike some of the other proposals before Congress, the Eshoo-Inslee-Barton bill preserves incentives for continued biomedical innovation to develop new treatments and breakthrough therapies. It would allow the biologic's inventor to protect the proprietary data used in determining the safety and efficacy of the biologic for 12 years. After that period, the U.S. FDA can rely on the innovator's data to approve a competitor's product. A similar process and timeline currently exists for the development of generic versions of traditional medicines.
This timeline was recently endorsed by the Senate's influential Committee on Health, Education, Labor and Pensions when the Committee affirmatively voted to establish 12-year period of exclusivity in its version of biosimilars legislation.