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BIO Submits Comments on Nonproprietary Naming of Biological Products

<p>
The Biotechnology Industry Organization (&ldquo;BIO&rdquo;) thanks the Food and Drug Administration (&ldquo;FDA&rdquo;) for the opportunity to submit comments on the Draft Guidance entitled &ldquo;Nonproprietary Naming of Biological Products&rdquo; (&ldquo;Draft Guidance&rdquo;).</p>

BIO strongly supports FDA’s progress in implementing the Biological Price Competition and Innovation Act (“BPCIA”). As we have stated on many occasions, the BPCIA, which BIO endorsed and which passed Congress on a bipartisan basis, was intended, first and foremost, to operate in the best interest of patients by providing them and their healthcare providers with additional choices of safe and effective medicines. BIO believes that patients are best served by medicines, including biosimilars, approved by FDA on the basis of excellent science demonstrating the products’ safety and efficacy and, in the case of biosimilars, demonstrating that the products are highly similar to their reference biologics. Accordingly, we are pleased to offer the following comments on FDA’s Draft Guidance on Nonproprietary Naming of Biological Products.