BIO, GPhA and Sandoz testify at FDA biosimilars hearing

SILVER SPRING, Md. The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of generic drugs, testified Wednesday at a hearing sponsored by the Food and Drug Administration to collect public and industry input on the implementation of the regulatory approval pathway for follow-on biologics included in the healthcare-reform bill.


Biotechnology Industry Organization EVP health Sara Radcliffe said the regulations should emphasize patient safety and incentives for innovation. During debates over the pathway, BIO was on the side of groups that said the regulations governing follow-on biologics, also known as biosimilars, should include a data exclusivity period of 12 years — meaning that the FDA would have to wait 12 years after a biotech drug has hit the market before approving a follow-on version. The generic drug industry, represented by the Generic Pharmaceutical Association, as well as several consumer and patient advocacy groups, favored a five-year exclusivity period similar to the one used for pharmaceutical drugs.



“BIO supported the passage of legislation to enable the FDA to approve biosimilars,” Radcliffe said in her testimony. “As the FDA considers how best to implement the pathway for approving biosimilars, we call on the agency to make patient safety the top priority while preserving incentives for future biotech innovation.”



Mylan VP and head of global biologics research and development Rasmus Rojkjaer testified on behalf of the GPhA, saying that a science-based approval process is needed to ensure lower costs to patients and warning against legal loopholes that would allow exclusivity periods for biotech drugs to be extended indefinitely.



“GPhA believes the Biologics Price Competition and Innovation Act passed earlier this year as part of national healthcare-reform legislation was a cautious first step toward establishing a regulatory approval process for biogeneric products,” Rojkjaer said.



Meanwhile, Sandoz, the generics division of Swiss drug maker Novartis, emphasized the importance of regulations recognizing biosimilarity, meaning a high degree of similarity between an original biotech drug and a knock-off version as demonstrated through a streamlined clinical trial process; the use of supportive data, such as the use of data on biosimilars from other countries when considering whether to approve them for the U.S. market, as long as the product is produced and marketed under the same standards as the U.S. version; and interchangeability between an original biotech drug and a biosimilar.



Sandoz has marketed biosimilars in Europe for several years, alongside Israel-based Teva Pharmaceutical Industries and U.S.-based Hospira. It also markets the biosimilar human growth hormone Omnitrope (somatropin) in the United States, a biosimilar of Pfizer’s Genotropin, under a special approval obtained from the FDA in 2006.



The Pharmaceutical Research and Manufacturers of America also testified Wednesday, releasing a summary of its testimony to Drug Store News Tuesday.


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