Statement Concerning Senate Letter to FDA Commissioner Margaret Hamburg

  • Contact: George Goodno
  • Phone: 202-962-6660
  • Email: ggoodno@bio.org
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Six U.S. Senators submitted a letter on October 23, 2013 to FDA Commissioner Margaret Hamburg, wherein they expressed concerns relating to naming standards for biosimilars - drugs that are similar to, but not the same as the innovator drugs they seek to replicate.

BIO strongly opposes naming products in a way that will create confusion for physicians and patients and will hinder effective pharmacovigilance. Use of the same nonproprietary name suggests something that is not true for biosimilars - that they are the same as the innovator drugs they reference. When ultimately approved by the FDA, biosimilars will be similar to, but not the same as, their respective reference products.

Congress left it to the experts at FDA to make the decision about product names - as the agency does for every other product.  Reserving this to FDA will allow for thorough consideration of technical, scientific and patient safety issues involved. 

Minor differences between innovator and biosimilar products could lead to real differences for patients, therefore it would be inappropriate to permit use of the same nonproprietary name for biological products that are not the same from a regulatory or scientific perspective.

About BIO
BIO is the world's largest trade association representing 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 BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO's blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.