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.
Budget Impact Analysis of Biosimilar Natalizumab in the US
Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
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.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Hesitancy in MENA Nations to Adopt WHO Biosimilar Guidelines Hinders Market Development
July 17th 2024The World Health Organization’s (WHO) new guidelines for biosimilar approvals aim to save time and money for manufacturers in the Middle East and North Africa (MENA), but hesitancy among nations to adopt the guidelines is stifling market development of biosimilars.
BioRationality: Time to Get Rid of PBMs if Biosimilars Are to Succeed
July 15th 2024Sarfaraz K. Niazi, PhD, discusses the challenges with pharmacy benefit managers (PBMs) that plague the biosimilar industry and new legislation that attempts to reform their practices and encourage biosimilar adoption.