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Reducing the exclusivity period for biologics would save the federal government and taxpayers $6.9 billion over the next 10 years, according to the U.S. Department of Health and Human Services’ 2017 budget request. In addition, several studies estimate the projected savings from the approval of biosimilars to substitute for high-cost biologics could range from $44 billion to $250 billion over the next decade, according to a release from Sen. Brown’s office.
“Essential prescription drugs, especially biologics, have been priced far too high for far too many people to afford and for taxpayers to have to pay for,” Brown said, noting that the leukemia-fighting biologic, Glevic, was introduced in 2001 at a cost of about $26,000 a year, and today the annual price tag is $120,000.
The proposed legislation is being trotted out as the drug industry is getting hit with backlash over what is seen as the exorbitant prices that have been put on many new meds, as well as its practice of routinely ratcheting those up.
There are federal investigations and Congressional hearings into drug pricing and state attempts to set limits on drug prices since federal efforts have repeatedly been stymied by a deadlocked Congress.
Biologics have been major moneymakers for drug companies, but the companies say they must consider the cost of research and manufacturing, which often involves the use of expensive recombinant DNA technology, when pricing biologics.
An industry group of companies that have developed biologics said it “strongly opposes” the proposed exclusivity reduction.
“This legislation is a short-sighted attempt to undercut the critical work that innovator companies are doing and would, if enacted, deprive patients of many new treatments and cures in the future,” the Biotechnology Innovation Organization said in a statement.
Brown said such justifications are dubious, at best, and shouldn’t preclude lower-cost options for consumers: “Research costs don’t go up after drugs are on the market, so this really is abusing the system.”
Dr. Nnodum Iheme, a pharmacist and founder of ZIKS Family Pharmacy in the Wright-Dunbar neighborhood, said the proposed legislation would not only drive down prices and save taxpayers money, it would provide a major incentive for drug companies to accelerate the development of biosimilars and lower-cost biologics.
“Biosimilars and biologics are very effective and safe pharmacotherapy,” Iheme said. “A generic biologic will help a lot of people, save money and enhance better health outcomes.”
Researchers at Johns Hopkins University and Brigham and Women’s Hospital studying a specific group of biosimilars used to treat inflammation for patients with rheumatoid arthritis and inflammatory bowel syndrome found the biosimilars used were “interchangeable” with more expensive brand-named biologics used for the same treatments, according to their study published in the Annals of Internal Medicine.