Wayne Winegarden, PhD
To the extent that the net prices of Humira and Enbrel increase before the introduction of competition, then the potential savings enabled by biosimilar competition would increase.
The conservative think tank Pacific Research Institute (PRI) calculated potential biosimilar savings across multiple market share scenarios.
A study from a free market–focused think tank argues for the elimination of market barriers to biosimilars to tap potentially billions of dollars in health care system savings that biosimilars for 2 widely used drugs could provide.
The study from the Pacific Research Institute (PRI) in California analyzed the potential impact of biosimilars for AbbVie’s adalimumab (Humira), the top-selling drug in the United States, and Amgen’s etanercept (Enbrel). Both therapies treat rheumatoid arthritis and other autoimmune conditions.
Annual systemic savings could total up to $5.8 billion, with $4.7 billion resulting from biosimilars for Humira and $1.1 billion from drugs that are interchangeable with Enbrel, said Wayne Winegarden, PhD, director of PRI’s Center for Medical Economics and Innovation and the study’s author.
“These calculations emphasize the importance of promoting an environment that empowers competition once the originator’s exclusivity period has expired. These reforms include eliminating barriers such as rebate walls and promoting positive reforms such as favorable formulary tiers for biosimilars,” Winegarden wrote.
The estimate is based on the maximum savings possible if new biosimilars for the 2 drugs were to achieve a 75% market share. The total savings would reach up to $3.9 billion at 50% market share, and between $1.3 billion and $1.9 billion at 25% market share.
Neither drug currently faces competition from biosimilars. Amgen has said it plans to begin marketing adalimumab (Amjevita), the European Union’s best-selling adalimumab biosimilar, in the United States in 2023. A commercial license for Boehringer Ingelheim’s adalimumab (Cyltezo) will begin in 2023, according to the company.
The FDA has approved 2 Enbrel biosimilars, Sandoz’s etanercept (Erelzi) and Samsung Bioepis’ etanercept (Eticovo), neither of which is available in the United States due to patent issues.
AbbVie’s Humira generated $16.11 billion in gross revenues and Amgen’s Enbrel earned $4.86 billion in 2020, according to the PRI study.
To the extent that the net prices of Humira and Enbrel increase before the introduction of competition, then the potential savings enabled by biosimilar competition would increase.
However, after considering rebates, fees, and discounts that the manufacturers pay, and projecting the change in sales from last year, Winegarden projected that the health care system will spend $10.3 billion on Humira and $2.5 billion on Enbrel doses in 2021.
The study used 3 scenarios for drug price discounts—40%, 50%, and 60%—that could occur if biosimilars for the drugs were available, and modeled the resulting ranges of systemic savings at different levels of market share gain.
Breaking the figures down by payer, commercial payers could save up to $2.9 billion for Humira and $707 million for Enbrel, state Medicaid programs could save up to $875 million and $214 million, respectively, and federal expenditures on Medicare and military insurance could decrease by up to $726 million and $175 million, respectively, the study estimated.
Payers in every state would benefit. The states with the highest projected savings are Florida, which would see spending reductions of $77 million to $347 million depending on the discount rate scenario and level of market share gain, and Pennsylvania, where the savings could fall between $78 million and $349 million.
“These calculations demonstrate that an environment that successfully fosters biosimilar competition in just these 2 biologic drug classes will generate significant systemic savings that will meaningfully improve the current drug affordability landscape,” Winegarden wrote.
Spanish Real-World Study: Adalimumab Biosimilar MSB11022 Safe, Effective in IBD
May 18th 2024A real-world study in Spain on inflammatory bowel disease (IBD) patients found no meaningful changes in clinical or biochemical markers or differences in effectiveness between the adalimumab originator and the biosimilar MSB11022 (Idacio; Fresenius Kabi) in adalimumab-naïve patients.
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.
Panelists Call for Consistent Education, Support to Improve Patient Comfort With Biosimilars
May 15th 2024At the Festival of Biologics USA, panelists stressed the need for patient-centered communication and education to boost comfort with biosimilars, emphasizing consistent support from health care providers despite restrictive payer policies.
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.
Patients With IBD Experience Nocebo Effect Post Mandatory Switch to Biosimilar
May 11th 2024In Canada, a study on patients with inflammatory bowel disease (IBD) switching to infliximab or adalimumab biosimilars found no change in clinical remission or antidrug antibodies after 24 weeks, but 13% experienced the nocebo effect, leading to one-fifth discontinuing therapy.
Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability
May 9th 2024As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.