Biosimilar Legal Roundup: November 2020

As the fate of the US biosimilar pathway was deliberated by the Supreme Court, experts weighed in throughout the month on what could be done to improve biosimilar access and uptake.

ACA Challenged in the Supreme Court

On November 10, the Supreme Court heard arguments on whether the individual mandate is severable from the Affordable Care Act (ACA). Caught in the middle of this argument is the Biologics Price Competition and Innovation Act (BPCIA), which outlines the regulatory pathway for biosimilars and is part of the ACA. The individual mandate, which was found to be unconstitutional, dictates that individuals must have health insurance or pay a penalty.

Chief Justice John Roberts, along with several associate justices, hinted that the ACA and BPCIA could be saved if the mandate is deemed severable, saying, “It’s hard for you to argue that Congress intended the entire act to fall if the mandate was struck down,” and that “there seems to be compelling evidence” that the intent of Congress was for the “rest of the law to survive if an unconstitutional provision were severed.”

In an expert column for The Center for Biosimilars^®, 2 intellectual property attorneys offered their opinion on the oral arguments, stating that although a ruling for severability is likely, “It is not unheard of” for justices to do something unexpected.

The Future of Biosimilar Legislation

Molly Burich, MS, associate director for Public Policy at Boehringer Ingelheim Pharmaceuticals, takes a cautious view of the potential for robust improvements in biosimilar access in the near future, but she offered a nugget of hope at the Association for Accessible Medicines GRx+Biosims 2020 conference, saying that current legislative efforts to boost biosimilar adoption have strong bipartisan support.

Burich examined 6 bills that have been introduced in the House of Representatives. These include bills that would eliminate patient cost sharing for biosimilars under Medicare Part B, increase incentives for providers to prescribe biosimilars, make patent information more accessible to developers, and increase biosimilar education efforts.