The Supreme Court’s ruling in the Affordable Care Act (ACA) case appears to have saved the biosimilars approval pathway, but do the plaintiffs have other avenues by which to bring another challenge?
On June 17, 2021, the Supreme Court ruled that opponents to the Affordable Care Act (ACA) did not have standing to challenge the law based on the constitutionality of the individual mandate, which provides for a penalty (currently $0) for those who do not obtain health care coverage. Had the Supreme Court struck down the entire ACA, it would have brought an end to the approvals pathway for biosimilars that is contained within the ACA under the Biologics Price Competition and Innovation Act.
The Center for Biosimilars® spoke with Stacie Ropka, PhD, a patent litigator and partner at Axinn, Veltrop & Harkrider of New York, New York, about the significance of this ruling and the conclusions that can be drawn from it.
Ropka discusses the narrow terms upon which the Supreme Court rejected the petition to strike down the ACA. The court ruled on the issue of standing—whether the plaintiffs had suffered harm because of the law—which they had not, rather than the merits of the case. The plaintiffs contended the individual mandate (Section 5000A) is an integral part of the ACA and therefore, if unconstitutional, should be struck down along with the entire ACA. The court never got to that argument.
Ropka explains what course of action may be available at this point for the plaintiffs, a collection of GOP-governed states led by Texas. She discusses the dissenting opinion on the high court and weighs the significance of the ruling for Congress, which created the ACA and now has an opportunity to make it more watertight, or not.
For background reading on the ACA case, read about the June 2021 ruling here, and for background on the withdrawal of the Department of Justice from the plaintiffs’ side of the suit, click here.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Revolutionizing Biopharmaceuticals: The EU's Biosimilar Success and Remaining Challenges
October 16th 2024The European Union's (EU) approach to biosimilars has revolutionized the biopharmaceutical market by driving innovation, lowering costs, and increasing adoption; however, there remains a need for more education, real-world evidence, and efforts to address challenges to enhance patient access and affordability.