Late in April, the Biotechnology Industry Organization (BIO; Washington, DC, USA) submitted a citizen's petition to the US Food and Drug Administration (FDA; Rockville, MD, USA), requesting an open public discussion of agency policy regarding “follow-on” biologics—that is, therapeutic proteins and other biotechnology products that may someday be marketed as generic products. Agency officials are granted 180 days before they are required to respond to the BIO petition, and so far are not showing signs of rushing pell-mell into this potential policy quagmire.
BIO brought this petition to the FDA in part as a response to informal public statements made by several top FDA officials indicating a growing willingness to consider at least certain biotech products under an evaluative umbrella similar to the one being applied to conventional small molecular drug entities. Although muted in tone, BIO's petition lays the groundwork for a more combative approach if FDA aggressively adopts a pro-generics approach regarding biotechnology-derived therapeutics or recombinant hormones, such as human insulin and growth hormone, whose patents will be lapsing in the United States relatively soon, and even sooner in Europe (see Box 1). “These issues are percolating at FDA and will undoubtedly result in litigation” against the FDA if BIO's concerns are not taken seriously, says Steve Lawton, BIO's vice president for regulatory affairs and general counsel.
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