Industry group letter indicates qualified aupport for bill to allow approval of generic biotechnology medications

May 19 2008

The Biotechnology Industry Organization has issued a letter to Reps. Anna Eshoo (D-Calif.) and Joe Barton (R-Texas) to indicate qualified support for a bill (HR 5629) that they have introduced to allow FDA to approve generic biotech medications, CQ HealthBeat reports (McCarthy, CQ HealthBeat, 5/16).

The legislation would provide brand-name biotech companies with at least 12 years of market exclusivity before generic versions of their medications could reach the market. In addition, the bill would require clinical trials for generic versions of biotech medications, although FDA could waive the requirement. Under the bill, FDA could classify generic versions of biotech medications as interchangeable with brand-name versions at pharmacies, provided that the agency has developed guidance on the evidence required to prove interchangeability for a product class (Kaiser Daily Health Policy Report, 3/17).

In the letter, BIO President and CEO Jim Greenwood wrote that the group supports the legislation but seeks an increase in the period of market exclusivity from 12 to 14 years to encourage the development of new biotech medications. "Data exclusivity is absolutely necessary to preserve incentives for innovation," he wrote, adding, "A follow-on biologic -- by definition -- will not be the same as the innovative product, and thus, without data exclusivity, a follow-on manufacturer may produce a follow-on biologic that is 'similar enough' for regulatory approval purposes but different enough so as to avoid the innovator's patents" (CQ HealthBeat, 5/16).