Nature Biotechnology responds:

The creation of an approval process for protein generics is an issue to truly test the vision and resolve of BIO's leadership. Clearly, as reported in a News Feature by Stephan Herrera in the November issue (Nat. Biotechnol. 22, 1343–1346, 2004), many of BIO's most powerful members, such as Genentech (S. San Francisco, CA, USA) and Pfizer (New York, USA), have a strong vested interest in delaying the introduction of a streamlined approval process for follow-on proteins. The question is whether BIO can balance the need for more affordable biotech drugs with “science and patient safety” and the business interests of many of its members to protect their markets and shareholders. Calling for public meetings with stakeholders is a necessary first step. But as long as the discussions continue without an end in sight and little concerted effort to find a workable compromise for brand and generic companies, Congress and the public will perceive that industry is stalling. As Herrera wrote in his article, BIO dithers at its own peril. If biotech firms cannot figure out a way to function in a post-proprietary world like the pharmaceutical industry has, Congress and the courts will show them how.