Biden plan would axe interchangeable status for biosimilars

President Joe Biden’s budget proposal for fiscal 2025 includes a proposal that would allow pharmacy substitution of biosimilar drugs for the reference product, even if they are not designated as interchangeable.

The plan would remove the current requirement for additional studies, sometimes clinical trials, that may be needed by the FDA to show that biosimilars are interchangeable, in other words, that they will not have diminished efficacy or an increased risk of safety concerns if patients switch back and forth between a brand and biosimilar.

The FDA’s authority to designate biologics as interchangeable was created by the Biologics Price Competition and Innovation Act, which came into force in 2010. However, budget documents claim that “the statutory distinction between biosimilars and interchangeable biosimilars has led to confusion and misunderstanding […] about the safety and effectiveness of biosimilars and about whether interchangeable biosimilars are safer or more effective than other biosimilars.”

The White House goes on to say that making all biosimilars interchangeable would make the regulation of these products “more consistent with current scientific understanding, as well as with the approach adopted by other major regulatory jurisdictions, such as the [EU], where biosimilars are interchangeable with their respective reference products upon approval.”

The aim is to encourage greater use of biosimilars, which tend to be lower-priced than the original brand, in the US market. Factors such as the interchangeable requirement, formulary access among pharmacy benefit managers (PBMs) and a lack of awareness of biosimilars and experience with using them have all been cited to explain the lower uptake of these drugs in the US than other markets, such as Europe.

The proposal is part of a long list of measures aimed at reducing the cost of medicines in the US in the budget, along with limits to the three-year exclusivity of the Hatch-Waxman Act, protections from litigation for companies that file generics with so-called skinny labels – i.e. seeking approval for some, but not all, of the indications of the brand to sidestep patent protections – and requiring full disclosure of all the ingredients in products, including excipients, which would assist generic developers.

While the budget has little chance of making it through Congress in its current form due to the bipartisan impasse, it gives a clear indication that Biden does not intend to rein in his campaign on medicine pricing.

It has been published on the heels of the President’s State of the Union address, in which he trumpeted legislation to allow Medicare to negotiate drug prices – and plans to extend the number of drugs that will be subject to those discussions – saying that showed “we finally beat big pharma.”

He also pointed to a $35-per-month insulin price cap and $2,000-per-month prescription drug cost cap, which are also covered in the budget with proposals to extend both those caps beyond Medicare and into the commercial market.

In a statement, the White House said the measures to lower drug prices “will not only cut costs for the federal government by $200 billion; they will also save billions of dollars for seniors.”

In a response to the budget, House Republicans said it is “yet another glaring reminder of this Administration’s insatiable appetite for reckless spending and the Democrats’ disregard for fiscal responsibility.”

Photo by David Everett Strickler on Unsplash