Patent Baristas

It appears, for now at least, that the legislation creating an approval pathway for follow-on biologics will not be included in the FDA Revitalization Act (FDARA). FDARA would reauthorize the Prescription Drug User Fee Act or PDUFA (pronounced puh-doo-fuh), which expires Sept. 30.

PDUFA increases funding for the Food and Drug Administration through fees paid by the drug companies, which increase the speed of drug approval at the FDA. The FDA attempts to review and act on at least 90% of the New Drug Applications and Biologic License Applications within 10 months of the date of filing and within six months for drugs given priority review. User fees have gone from being 7 percent of the FDA’s budget to 59 percent.

Many of the new additions to the PDUFA involve the FDA’s ability to increase drug safety in the wake of Merck’s (NYSE: MRK) Vioxx withdrawal. The House bill gives the FDA power to order companies to run additional clinical trials after the drugs have been approved for marketing and requires drug companies to make much of their clinical trial data available to the public. It also gives the FDA the ability to levy up to $250,000 fines for false or misleading advertisements.

A bigger issue is whether the FDA should approve generic biotech drugs or so-called follow-on biologics, sometimes called biosimilars or biogenerics. Unlike with small-molecule drugs, there’s no mechanism for generic-drug makers to gain approval for follow-on biologics.

The two versions of the bills, S. 1082 and H.R. 2900, are currently pending before a conference committee. The Senate version of the bill contains a placeholder for follow-on biologics legislation, but the House has not yet discussed the issue.

The Public Health Service Act, under which biologics are licensed, does not contain an abbreviated approval pathway analogous to the process used under the Food, Drug, and Cosmetic Act for generic drug approvals, according to the FDA. However, the agency has approved some follow-on biologics under the FD&C Act, such as GlucaGen, Hydase, Fortical and Omnitrope.

The Senate Health, Education, Labor and Pensions Committee passed the Biologics Price Competition and Innovation Act, S. 1695, by unanimous voice vote earlier this summer, establishing a way for the FDA to approve products as biosimilar to existing biologics. S. 1695 would grant 12 years of data exclusivity to innovator biologic drugs.

Under the bill, a follow-on biologic applicant would be required to demonstrate that there are no clinically meaningful differences in safety, purity and potency between its product and the brand product. The bill also allows the FDA to approve a follow-on biologic as interchangeable. However, the applicant must provide evidence that its product will produce the same clinical result as the brand product in any given patient and that it presents no additional safety risks or diminished efficacy if a patient alternates or is switched between products.

S. 1082 also includes language that prohibits the FDA from delaying approval of a generic drug on the basis of a citizen’s petition unless such a delay is necessary to protect the public health, according to a summary of the bill. In addition, it requires the FDA to take final action on a petition no later than 180 days after its submission unless such a delay is necessary.  The use of citizen petitions has been an effective tactic in delaying generic entrants to the market, such as with Wyeth’s injectable antibiotic Zosyn (piperacillin/tazobactam).

Recent news from Congress is it’s abandoning follow-on legislation and will address biogenerics in a separate bill. This will allow PDUFA IV to finally pass but, given the fact that sales of biotech drugs were $40.3 billion last year, this issue is far from dead.