WASHINGTON — Food and Drug Administration Commissioner Scott Gottlieb Wednesday blamed pharmaceutical companies for manipulating rebates to stymie competition, which blocks patients’ access to affordable copycat drugs and costs them billions in higher-cost medicine.
Drug makers discourage health plans from switching to biosimilars, cheaper copies of branded biotech drugs, by offering big rebates in multi-year contracts for keeping only costly biotech medicines on their lists of approved drugs, Gottlieb said in a talk at the Brookings Institution Wednesday. When new biosimilars are launched, they only have access to roughly 15% of the market and they often cannot discount their prices enough to compete with those rebates, he said.
“The branded drug industry didn’t build its success by being business naive,” Gottlieb said, “They are smart competitors. But that doesn’t mean we need to embrace all of these business tactics, or agree that they’re appropriate.”
If Americans could have bought FDA-approved biosimilars last year, they could have saved more than $4.5 billion, Gottlieb said, citing an analysis that the FDA will release soon.
Commercial payers and Medicare could save up to $465 million annually from the increased use of biosimilars to replace just one biologic drug, according to a report published in June by Pacific Research Institute. The copycat versions of inflammation drug Remicade, marketed by a Johnson & Johnson unit in the U.S., can save up to $4,400 a year for one patient, the report said.
“While the FDA has approved 11 biosimilars through 2018, only three are now marketed in the U.S.,” Gottlieb said. “Competition is, for the most part, anemic.”
The FDA has been using new review tools that are tailored to applications for biosimilar products in order to speed up the approval process and boost competition, Gottlieb said. The FDA also released a finalized guidance on the labeling of biosimilar products Wednesday.
The development of biosimilars in the United States has lagged behind that in Europe, where 25 biosimilars have been authorized.
Litigation over intellectual property rights has delayed biosimilar products that are already available in other countries.
“These delays can come with enormous costs for patients and payers,” Gottlieb said, but declined to comment on specific cases.
The FDA is seeking to strengthen its partnerships with regulators in Europe, Japan and Canada, Gottlieb said.
“We’re actively exploring whether data-sharing agreements could give us better insights into biosimilars’ real-world safety and efficacy,” Gottlieb said.
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