HATCH, WAXMAN PUSH FDA TO ACT ON FOLLOW-ON BIOLOGICS ISSUE
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.