BIO argues case for retaining 'biosimilars' legislation in US health care reform package

The USA's Biotechnology Industry Organization (BIO) issued the following statement in response to a letter recently sent by the Generic Pharmaceutical Association (GPhA) to the White House requesting the Obama Administration to urge Congressional leaders to strike biosimilars provisions from health care reform legislation unless the provisions are 'materially altered' (The Pharma Letter October 30):

"GPhA's request to the Administration is a cruel trick to the millions of patients who are awaiting the benefits of biosimilars. GPhA is asking the Obama Administration to hold patients and consumers hostage unless it gets its way on this critical provision of health care reform. It's not surprising that GPhA is asking for delay given this is exactly what they did in 2007 after the Senate Health, Education, Labor and Pensions Committee (HELP) Committee passed a similar proposal, unanimously. What is surprising is how brazen this powerful lobby is acting today. The innovator biotechnology industry actively supports efforts to expand competition in our sector through our strong support of the bipartisan Committee-passed regulatory pathway for biosimilars.

'Biosimilars, often erroneously referred to as 'generic biologics', can bring the benefits of expanded competition to biologics, breakthrough medicines that are extending and saving the lives of patients living with diseases such as cancer, diabetes, Parkinson's and Alzheimer's. Well-crafted legislation, such as the language passed out of the HELP and the House Energy and Commerce Committees, lays out an approval pathway for biosimilars that protects patient safety, lowers prices, expands access and provides the incentives necessary to develop new breakthroughs and, one day, cures. This language is supported by more than 150 organizations representing patients, physicians, universities, venture capitalists, labor unions, local chambers of commerce and innovators. This approach also is supported by the governors of 11 states. These disparate interests recognize that a base 12 years of data exclusivity, as provided in the House and Senate language, is critical to ensure the development of the next generation of therapies for patients, lower costs for consumers, and continued job creation within the biotech industry.

'GPhA continues to bend the truth about biosimilars and the language passed in the House and Senate Committees. Despite GPhA's misleading claims to the contrary, the biosimilars provisions regarding the original product explicitly prohibit any extension to the 12-year exclusivity provision as a result of any change to the product, minor or major. 

'Providing a company with data exclusivity does not give it or extend any sort of monopoly. Products that compete with innovative biologics can still be introduced during the period of data exclusivity. They just cannot piggyback off of the research conducted by the innovator company. They must conduct their own safety and efficacy research and testing to obtain FDA approval and, obviously, not infringe the patents of the pioneering company.'