In November, the Supreme Court heard arguments on the Affordable Care Act, Europe fired up its efforts to create a more biosimilar-friendly environment, and Genentech fought to protect its bevacizumab franchise.
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.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.
Rising Biosimilar Adoption for an Italian Payer Will Benefit National Health Care System, Patients
April 9th 2024Data from 2021 and 2022 indicates increasing biosimilar use in an Italian health care company, with potential for full adoption in the future, benefiting both the National Health System and citizens through efficient and sustainable health care policies.