Alexandra Valenti, JD, associate at Goodwin, discusses the future of the Biologics Price Competition and Innovation Act (BPCIA) in light of challenges to the Affordable Care Act.
Transcript
So, the [Biologics Price Competition and Innovation Act, BPCIA] was enacted as part of the Affordable Care Act, and there was a recent successful challenge on constitutional grounds to the Affordable Care Act before a District Court in Texas. That decision is up on appeal now before the Fifth Circuit, and the Department of Justice has submitted a brief saying not only should the Fifth Circuit affirm that decision, but it should further find that provisions of the Affordable Care Act other than the individual mandate provision, which is the subject of the constitutional challenge, should be found to be not severable from the rest of the statute, meaning that if one provision of the statute goes down, so too the rest of the statute.
So, the question of whether the constitutional challenge to the Affordable Care Act has any effect on the BPCIA will hinge on that question of severability and whatever court makes the ultimate decision on this question, whether that be the Fifth Circuit or the Supreme Court in this case, finds that the individual mandate is severable from the rest of the statute. Of course, this doesn’t matter if the courts ultimately decide that the individual mandate provision is constitutional.
Interestingly, in the original challenge to the Affordable Care Act back in 2012, that was [National Federation of Independent Business v Sebelius], before the Supreme Court, President Obama’s Department of Justice submitted a brief that argued that the rest of the statute should not be found to be severable from the individual mandate because Congress would not have enacted the entire statute without the Individual Mandate Provision. So, it’s interesting to see the Obama administration and the Trump administration taking essentially the same position on the same issue.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
Eye on Pharma: Celltrion, Costco Partnership; Amgen Sues Samsung Bioepis; Denosumab Results
August 21st 2024Celltrion's adalimumab-aaty biosimilar is now accessible for all Costco members, while Amgen sues Samsung Bioepis over the latter’s denosumab biosimilar candidate, and GlycoNex progresses its denosumab biosimilar SPD8 to phase 3 trials.
Patent Dance Insights: A Q&A on Reducing Legal Battles in the Biosimilar Landscape
August 18th 2024In an interview, Ha Kung Wong, an intellectual property attorney, explained that the Biologics Price Competition and Innovation Act of 2009 provides a structured but optional "patent dance" for biosimilars, which helps streamline patent disputes, potentially reducing litigation and encouraging early settlements.