September 29, 2005

The FDA's current policy on follow-on biologics amounts to a "monopoly" situation for brand firms, according to Rep. Henry Waxman (D-Calif.), who joined Sen. Orrin Hatch (R-Utah) this week to push the FDA to take action on the issue.

With the number of biologic products on the market starting to multiply, there is a strong need to balance biotech innovation with competition, the lawmakers told attendees at the Generic Pharmaceutical Association's (GPhA) first annual policy conference.

The current situation "effectively grants a perfect monopoly for these medicines," Waxman said. He called for the FDA to develop a "case-by-case" approach similar to one under development by the European Medicines Agency, where "compatibility studies" would be required to prove that a biologic and a generic version of the drug were similar enough to be considered equivalent.

Hatch, meanwhile, urged the FDA to "fast-track" drug applications for generic biologics, citing the huge costs for "wonder therapies" like human growth hormone, which he noted can cost as much as $25,000 a year.

The senator said he has inserted language into the FDA's funding bill, the Agriculture Appropriations bill, requiring the FDA to report on its efforts to develop a regulatory pathway for generic biologics. However, Hatch said a Senate "colleague" is trying to include language in the bill that would not allow the FDA to look at section 505(b)(2) as a potential pathway for reviewing and approving biogenerics. Some simpler biologic drugs have historically been approved under the statute.