The FDA has so far approved 11 biosimilars, drugs that should be saving patients billions of dollars. But so far, only three of the 11 have made it to the market in the U.S., a fact FDA Commissioner Scott Gottlieb, M.D., is blaming on the reference drugmakers that have thwarted biosims.
The FDA chief said some drugmakers are using “unacceptable” tactics such as litigation and rebate schemes to stall the entry of cheaper copies. While most of these fall outside the authority of the FDA, Gottlieb is promising to take action.
“We’re not going to play regulatory whack-a-mole with companies trying to unfairly delay or derail the entry of biosimilar competitors. We’re not going to wait a decade or more for robust biosimilar competition to emerge,” Gottlieb said in a prepared speech in front of a Brookings Institution event Wednesday.
According to an FDA analysis Gottlieb said will be released soon, the U.S. could have saved more than $4.5 billion in medical spending in 2017 if all FDA-approved biosims had been successfully marketed in a timely fashion.
“The branded drug industry didn’t build its success by being business naïve. They are smart competitors. But that doesn’t mean we need to embrace all of these business tactics, or agree that they’re appropriate,” said Gottlieb. “Some of these tactics should be unacceptable to every member of the drug supply chain.”
Though litigation is indeed a way to protect intellectual property, it has also been used to hold off biosimilar and generic rivals. Amgen, for example, has used patent lawsuits to prevent a biosimilar to its rheumatoid arthritis blockbuster Enbrel from entering the U.S. market. Novartis’ Sandoz won FDA approval for the copycat in August 2016, and another version by Samsung Bioepis is already being sold in Europe.
AbbVie’s thicket of patents protecting its megablockbuster Humira has deterred potential challengers Amgen, Samsung Bioepis and most recently Mylan, each of which struck settlements with AbbVie to delay their biosimilar challenges in the U.S.
It’s not just litigation that blocked many biosim competitions, Gottlieb said the agency is seeing drugmakers “thwart competition by dangling big rebates to lock up payers in multiyear contracts right on the eve of biosimilar entry.”
Gottlieb made the remark as the agency released its much-anticipated Biosimilars Action Plan (BAP). Although neither patent litigation nor payer contract falls within the FDA’s jurisdiction, the agency has its own 11-pronged plan to help enliven the stagnant biosimilar market.
Four measures Gottlieb highlighted in his speech include increasing efficiency of biosimilar and interchangeable product reviewing process and policy clarity, as well as communicating with patients, physicians and payers to improve understanding of biosimilars. The agency is also establishing a new Office of Therapeutic Biologics and Biosimilars to improve coordination under the Biosimilar User Fee Act.
Credit Suisse analysts noted in a memo to investors Wednesday that the BAP didn’t provide more details on the development of interchangeable biosimilars. Currently, generics are widely “interchangeable” or seen as equivalents with brand-name drugs, but biosimilars approved by the FDA are deemed “highly similar,” meaning they are expected to produce the same clinical result. Deeming the interchangeable would make acceptance faster.
In his speech, Gottlieb also stressed that the FDA can’t do it alone, requesting public and private partners to “align reimbursement and formulary design to encourage appropriate biosimilar adoption.” For one part, Gottlieb said it is working with the Federal Trade Commission to address anticompetitive behavior.
Credit Suisse analysts figured it could lead to greater scrutiny on Johnson & Johnson’s volume-based discount to protect Remicade and AbbVie’s settlements to delay Humira biosimilar launches.