Reps. Waxman, Frank Pallone (D-N.J.), Nathan Deal (R-Ga.) and Jo Ann Emerson (R-Mo.) introduced a bipartisan bill (H.R. 1427, the "Promoting Innovation and Access to Life-Saving Medicine Act") that would give the Food and Drug Administration (FDA) authority to approve generic versions of biological drug products. The Senate is expected to introduce its version of the bill in the near future.
To date, the FDA has not published regulations that delineate the approval process for generic biological drugs, also known as "biosimilars" or "follow-on biologics." However, under H.R. 1427 generic biotech drug manufacturers could be granted regulatory approval if they demonstrate "no clinically meaningful differences" between the generic and brand name products.
The development of biotech drugs is much more complex than traditional chemically synthesized drugs. This complexity will add considerable time and cost to biotech drug development for generic manufacturers. Acknowledging that the more complicated manufacturing process is difficult if not impossible to replicate, the bill provides that the generic maker must show clinical equivalence rather than bioequivalence as is currently required for chemically synthesized drugs. The proposed bill also requires that the two products are highly similar in molecular structure and that they share the same mechanisms of action, if known. Alternately, the generic biotech drug manufacturer may establish that the product is "biogeneric," meaning interchangeable with the brand name product. Such products could be safely substituted for the pricier brand-name biotech drugs.
H.R. 1427 provides that the FDA may require the dissimilar product manufacturer to conduct pre-approval clinical trials to establish "no clinically meaningful differences" or post-approval trials as part of an on-going safety program.
The bill grants market-exclusivity periods that are consistent with chemical drug exclusivity under Hatch-Waxman. A novel brand name biotech product would be entitled to five years exclusivity, while a modified brand name product would be entitled to three years exclusivity. Both could be extended up to one year if new indications or pediatric uses are developed to the FDA’s satisfaction. The first manufacturer of an approved generic version of the brand name biotech drug would enjoy six months market exclusivity.