BIO Clarifies GPhA's Myths With The Facts.

WASHINGTON -- As the House of Representatives' Committee on Energy and Commerce holds a hearing today on follow-on biologics, the Biotechnology Industry Organization (BIO) issued a statement of facts in response to misleading public statements on follow-on biologics made by the Generic Pharmaceutical Association (GPhA) and others.

"Any discussion regarding the development of a pathway for follow-on biologics must focus on the facts and seek to protect patient safety and incentives for continued biomedical innovation," said BIO President and CEO Jim Greenwood. "The GPhA, and others in the generics industry, however, continue to play loose with the facts."

BIO detailed several points essential to the discussion on follow-on biologics to counter GPhA's misleading rhetoric:

* BIO member companies are committed to the development of innovative therapies and to making sure that patients have access to these treatments. A properly crafted pathway for approval of follow-on biologics can support both these goals. As we have long said, however, any legislation establishing such a pathway must ensure that these products are safe and effective, and maintain incentives for innovation.

* Small biotech companies, all but the top 10, account for two-thirds of the industry's clinical pipeline. The companies that comprise the U.S. biotechnology industry are primarily small, private start-ups heavily reliant on venture capital and years away from product commercialization. Failure to provide the necessary protections and incentives could fundamentally jeopardize the ability of small biotech companies to innovate.

* Small biotech companies support BIO's principles designed to guide the development of any legislative pathway to approve follow-on biologics. Leaders of BIO's Emerging Company Section (ECS) Governing Body, representing more than 600 emerging biotech companies, recently issued a letter expressing explicit support for BIO's principles. BIO's ECS is composed of companies that are developing their first commercial product and have fewer than 350 employees; 80 percent of these companies have fewer than 50 employees.

* Biotechnology companies bear enormous costs and high uncertainty. Biologics manufacturing facilities alone cost between $250 and $450 million to construct. While Teva, a single generic manufacturer, had a net income of $1.1 billion in 2005, publicly traded biotech companies lost a collective $4.1 billion that same year. Now, by pushing for rapid consideration and adoption of poorly crafted follow-on biologics legislation, generic manufacturers seek new profit opportunities while jeopardizing patient safety and biomedical innovation.

* No credible analysis of follow-on biologics suggests that there will be anything close to the savings in health care costs realized from generic drugs. Indeed, even if the follow-on biologics achieved a market share of 50 percent, a figure that is considered by many to be overly optimistic, the overall savings would be 5 percent to 12.5 percent, and that is only for those few products for which it is possible for a follow-on biologic to be approved. Europe, where a pathway for approval of follow-on biologics has existed for four years, has only approved two follow-on biologics to date, with minimal savings.

* The Food and Drug Administration (FDA) has not determined how interchangeability can be established for complex proteins. At an April congressional hearing, FDA Commissioner Andrew von Eschenbach said, "The science has not emerged for us to be able to determine when one [biologic] product can be substituted for another or if manufacturing changes will cause differences." European regulators have reached the same conclusion. Follow-on biologics should not be given to patients unless prescribed by their physician.

"The facts are clear," said Greenwood. "To date, biotechnology has created more than 200 new therapies and vaccines, including products to treat cancer, diabetes, HIV/AIDS and autoimmune disorders. Potential treatments for diseases such as Alzheimer's and Parkinson's -- among many others -- are being researched and developed. The biotechnology industry is proud of the strides we have made and excited about future breakthroughs.

"To reach this future," he continued, "we must ensure that efforts to broaden access to innovative biologics do not jeopardize future innovation or jeopardize patient safety. And we must not allow irresponsible rhetoric to replace thoughtful deliberation. The stakes are simply too high."

About BIO

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the annual BIO International Convention, the global event for biotechnology. www.bio.org

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