Biogeneric substitution: Time for an approval pathway from Congress

April 2, 2007

The terms being used to describe these generics-biogenerics, generic biologics, biological follow-on products, biosimilar drugs, generic biopharmaceuticals-are interchangeable, but the question of how to determine whether these generics are safely interchangeable with the branded products is only now starting to be answered.

Science-based principles

Another issue the biotechnology industry raises is whether creation of an approval pathway will interfere with the intellectual property rights and thus slow down future innovations in biotechnology.

Proposed legislation

The total absence of an approval process has the biogeneric industry basically spinning its wheels waiting for Congress to act. A bill creating a process at FDA had been submitted in both the House and the Senate in the 109th Congress but was never approved. In February, a bill was introduced in Congress to create an approval process. The Access to Life-Saving Medicine Act (ALSMA) was introduced in the House by Rep. Henry Waxman (D, Calif.). Waxman, who, with Sen. Orrin Hatch (R, Utah), created the regulatory process for speeding approval of traditional generic drugs in 1984, is now chairman of the Committee on Oversight and Government Reform. The new bill is supported by senators Charles Schumer (D, N.Y.) and Hillary Rodham Clinton (D, N.Y.), and has bipartisan support in both houses.

ALSMA requires that an application for a biogeneric drug must demonstrate that there are no clinically meaningful differences in safety or effectiveness between the generic and the branded product and that it has highly similar "principal molecular structural features" and the same mechanism of action. It also states that clinical trials or other studies may be required, but that this will be decided on a case-by-case basis by the Secretary of Health & Human Services. A patent holder must disclose relevant patents when asked, and if this is not done or a relevant patent is not disclosed, the patent holder cannot enforce the patent against the applicant. Patent infringement actions must be brought within 45 days of notice of a challenge.

"In the current debate on generic biologics, we are hearing many of the same arguments we heard 22 years ago when we fought to enact Hatch-Waxman," said Waxman in an e-mail. "The drug industry argued that competition from generic drugs would harm patients and destroy incentives for innovation. We know now that not only are generic drugs good for patients, both medically and economically, but that competition does not bankrupt the drug industry or squelch innovation. The science and the economics all lead to the same conclusion: The time has come to establish a clear pathway for approving generic versions of biopharmaceuticals in the United States."