Nelson Quoted on SCOTUS ACA Ruling and the Future for Biosimilar Approvals

Partner Kevin Nelson was quoted on the U.S. Supreme Court ruling in California v. Texas that upheld the constitutionality of the Affordable Care Act (ACA) and its provisional pathway for biosimilar and biologic drug approvals, the Biologics Price Competition and Innovation Act (BPCIA).

Kevin said, “We’ve all breathed a collective sigh of relief when ACA was not struck down as unconstitutional. Without this structure, we would be back to square one with biosimilars.”

Before the passage of the BPCIA, Kevin said that there was no process for biologic approvals and that the bar was much higher for biosimilar manufacturers to indicate the scientific effectiveness of their drug. He noted there was also no structure for litigating these applications at the time, leaving prospective manufacturers unsure of what their legal risk looked like when undertaking development.

“We’re talking about significant cost outlaid to even begin the process,” Kevin said. “But we’re also talking about drugs that are worth several billion dollars for chronic diseases in a country that is known for having chronic diseases as a normal state of being.”

The passage of the BPCIA in 2010 provided necessary industry guidance. Kevin pointed to an additional 2018 rule allowing doctors to receive a six percent bonus for prescribing biosimilars has also been key for accelerating development.

“There’s more incentive for doctors to prescribe it and more incentive for people to pay for it,” Kevin said. “You’re creating a market. You’re incentivizing people to go into biosimilars, to make biosimilars, and to lower drug costs.”

Kevin noted some areas for improvement in the process of bringing biosimilars to market, such as more diversified offerings from biosimilar manufacturers, automatically prescribing biosimilars for newly diagnosed patients, and the “Lower Costs, More Cures Act of 2021,” which would temporarily raise the prescribing bonus to eight percent.

He said, “There’s just too much at stake. We need to improve the way that we educate people around biosimilars and the benefits and the safety, we need to further improve the reimbursement aspect to increase uptake and we need to improve what we can expect from the approval pathway, but also in the litigation structure.”

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