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BIO Submits Comments to WHO on INN Biological Qualifier for Biosimilars

<p>
The Biotechnology Industry Organization (BIO) thanks the World Health Organization (WHO) for the opportunity to submit comments on &ldquo;INN Working Doc. 14.342 - Biological Qualifier: An INN Proposal.&rdquo; BIO commends WHO on the release of this proposed policy, which aims to create a consistent, global system for ensuring that all biological products are identified by a unique Biologic Qualifier (BQ).</p>

For nearly a decade, BIO has advocated actively for a nonproprietary naming convention that ensures all biological products are distinguishable. BIO believes that a distinguishable nonproprietary naming convention would best facilitate pharmacovigilance, ensure accurate attribution of adverse events to the correct product, prevent inappropriate substitution and unintended switching, and support tracing of products in the event of a recall. In short, BIO strongly believes that distinguishable nonproprietary names enhance patient safety. Thus, BIO supports the development of a system under which nonproprietary names of biological products that are similar to each other in structure and function are distinguishable, but morphologically related, and easy to recognize, remember, and report accurately.