BIO Statement on World Health Organization Proposed International Nonproprietary Naming (INN) Policy for Biologic Medicines

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Washington, D.C. (July 31, 2014) – The following statement may be attributed to BIO President and CEO Jim Greenwood:

“BIO played a leading role in the effort to establish a pathway for the approval of biosimilars in the United States and believes that their introduction into the marketplace is important for patients.  Biosimilars, however, raise novel and complex questions of science and law that require the updating of legal and regulatory frameworks to ensure, among other things, accurate product identification.  We applaud the World Health Organization (WHO) for recognizing this need by issuing “Biological Qualifier: An INN Proposal,” and we strongly support its intent to ensure that all biological medicines are distinguishable. We appreciate the WHO’s willingness to consider additional stakeholder input as to how best to effectuate this shared goal, and we look forward to providing detailed comments on the proposal.”

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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.