The survival of the biosimilars approval pathway seemed on surer footing today following oral arguments at the Supreme Court over the Affordable Care Act and the severability of its provisions.
The survival of the Affordable Care Act (ACA) without the individual mandate seemed a distinct possibility following oral arguments in the Supreme Court, and this bodes well for the survival of the Biologics Price Competition and Innovation Act (BPCIA), which is part of the ACA statute and enacts the pathway for biosimilar approvals.
“It’s hard for you to argue that Congress intended the entire Act to fall if the mandate was struck down,” Chief Justice John Roberts said. The individual mandate dictated that individuals must have health insurance or pay a penalty for not having it, although the penalty was abolished in 2019. The argument before the court is whether the ACA and its provisions can be salvaged without the mandate or if they must be struck down in their entirety.
Roberts said “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.”
The potential loss of the BPCIA was cause for concern in the biosimilars community, where the pathway has enabled 18 biosimilars to come to market so far, making lower-priced versions of costly biologics available to many patients and thereby expanding access to treatment. It is believed that a chaotic interruption to the development of the biosimilars market could erupt without the BPCIA and until Congress develops patch-up legislation as a replacement.
A decision on the case, California v Texas, is expected in the spring of 2021.
For more about the Supreme Court hearing, visit AJMC.com.
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.