The golden age of biotechnology is about to go platinum. Congress is inching closer to establishing a legal framework under
which the US Food and Drug Administration can approve the marketing and sale of generic biologic compounds (follow-on biologics)
much in the same way that it approves the marketing and sale of generic small-molecule drugs under the Hatch–Waxman Act.
Whatever the outcome of the current data-exclusivity debate in Washington, the exact terms of the compromise will be important
to only a small segment of the pharmaceutical and biotechnology industries. Of greater significance are the opportunities
that lie in the development of technology that enables one to demonstrate compliance with standards for establishing similarity
and equivalency between follow-on and innovator biological compounds.
The intense debate over a pathway for the approval of follow-on biologics demonstrates the importance of biotechnology to
this country and the industry's potential to revolutionize medicine and agriculture. Without question, the enactment of a
follow-on biologics approval pathway will unleash their potential, just as the Hatch–Waxman Act did for generic small molecules
in the 1980s.
Scott D. Locke
Patents and FDA
Exclusive rights to biological inventions may be obtained under national patent systems, which enable patent holders to prevent
competitors from making, using, or selling technologies that embody a claimed invention. As with small-molecule technologies,
new compounds, new formulations, and new methods for the manufacture, administration, and use of biologics provide fertile
grounds for obtaining patent rights for useful, new, and nonobvious inventions. In the United States, however, pharmaceuticals
and biologics require FDA approval before being introduced to the market.Because no current mechanism allows follow-on biologics
to receive expedited FDA review, companies that desire to produce these compounds have faced significant delays following
traditional new-drug-application procedures. These companies, unlike their generic small-molecule counterparts, cannot simply
piggyback on the work of the pioneering biologics companies even after a patent has expired. For patent-protected industries
not regulated by FDA, this impediment does not exist.
Incentives lie ahead
If new legislation enables FDA to allow follow-on biologics to come to market faster, then competition for pioneering biologic
companies will undoubtedly increase. Because time is money, economic incentives are likely to increase the number of companies
that manufacture bioequivalent compounds as well as the number of follow-on biologics brought to market. Innovator companies
may see a short-term decrease in profits as a result, but the change should force them to concentrate more on developing new
biologics and improving their existing drugs. The combination of increased pressure on pioneer companies and increased opportunities
for follow-on biologics companies may cause the biotechnology industry to be one of the first industries to emerge from the
current economic downturn.