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.
Challenges and Guidance in Biosimilar Assessment: An ISPOR Report on HTA Agency Approaches
May 14th 2024The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.
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.
Cordavis Report Outlines Strategies for Biosimilar Development, Access in the US Health Care Market
May 8th 2024Cordavis, a CVS Healthspire company, released a report detailing the current hurdles faced in developing and commercializing biosimilars in the US and highlighting efforts by the organization to enhance access and affordability for these products.
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.
Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars
May 2nd 2024Data from a Cencora study showed some misalignment in payer coverage of granulocyte colony-stimulating factor (G-CSF) biosimilars, highlighting that while filgrastim biosimilars are often favored over the originator, reference pegfilgrastim still dominates over its biosimilars.