NEW YORK Many people have a lot to say about the recently passed healthcare bill, but generic drug makers have focused their attention on one area in particular.
Sandoz, the generics arm of Swiss drug maker Novartis, said it welcomed the bill’s inclusion of an abbreviated regulatory approval pathway for follow-on biologics, known variously as “biosimilars” and “biogenerics.”
Sandoz compared the creation of a biosimilars pathway with the Hatch-Waxman Act of 1984, which created an abbreviated pathway for generic pharmaceutical drugs, and expressed confidence in the FDA and eagerness to work with the agency.
But the pathway has its detractors as well, including the Generic Pharmaceutical Association, an industry trade group for the generic drug industry. The bill grants biotech companies a 12-year period of data exclusivity, meaning that the FDA would have to wait until a biotech drug had been on the market for that long before it could accept for review an application for a biosimilar version; the 12-year figure is based on studies that have indicated it takes around 14 years from the time a branded pharmaceutical drug is launched before the generic becomes available. The data exclusivity period for pharmaceutical drugs is five years.
The issue of exclusivity periods has been a thorny one. For most in the generic drug industry, particularly the GPhA, five years would give biotech companies ample time to recoup their investments while also allowing faster access to cheaper alternatives to biotech drugs for patients, and GPhA president and CEO Kathleen Jaeger responded to the healthcare bill’s passage by saying it would provide a pathway for biosimilars “in name only.” Meanwhile, the biotech industry has said that longer exclusivity periods are necessary because biologics cost more to develop and manufacture than pharmaceuticals; also, biotech companies say, the unique properties of biotech drugs would theoretically allow a biosimilar manufacturer to circumvent an innovator’s patents, thus making patent protection with five years’ exclusivity ineffective.