In an article by Dr Joshua Cohen, he discusses the challenges facing the adoption of biosimilars in the US, particularly focusing on Medicare beneficiaries' access to these lower-cost alternatives to brand-name biologics like Humira.
Despite significant discounts of over 80% compared to the original Humira, more than 40% of Medicare beneficiaries still lack access to Humira-referenced biosimilars due to various factors, including pricing and reimbursement complexities.
AbbVie, the manufacturer of Humira (adalimumab), anticipates maintaining its market share until 2025 or 2026, as the drug continues to generate substantial revenue, reaching US$14.4 billion in sales in 2023 alone. This is despite the approval of Humira-referenced biosimilars by the US Food and Drug Administration (FDA) several years ago. Legal battles and a convoluted patent system have delayed the launch of biosimilars in the US, allowing Humira to maintain its monopolistic hold.
Dr Cohen also highlights the role of rebate schemes in influencing the uptake of biosimilars. These rebates, provided by drug manufacturers to pharmacy benefit managers (PBMs), often favour higher-priced originator products like Humira, thereby hindering the adoption of biosimilars. Medicare Part D coverage of biosimilars has drawn scrutiny for either excluding them from formularies or subjecting them to high patient cost-sharing, similar to the originator drug.
Efforts to address these issues include legislative proposals to promote access to lower-cost biosimilars within Medicare Part D, with requirements for coverage and cost-sharing adjustments. However, regulatory barriers and resistance from healthcare providers, compounded by confusing naming conventions for biosimilars in the US, continue to impede their adoption.
In contrast, Europe has seen greater success in biosimilar adoption, with biosimilars entering the market earlier and achieving significant market share. European purchasing practices, which favour lower-priced alternatives, and streamlined regulatory processes contribute to this success.
On 5 April 2024, Boehringer Ingelheim its plan to downsize a portion of its US salesforce in response to disappointing of its biosimilar version of AbbVie’s blockbuster arthritis treatment, Humira.
By 30 June 2024, the company intends to trim its customer-facing teams, opting instead for a hybrid approach combining in-person and virtual sales strategies. This decision is primarily driven by the continued inclusion of branded Humira on pharmacy benefit managers' reimbursement lists.
Dr Cohen concludes by emphasizing the need for the US healthcare system to address barriers to biosimilar access, as prolonged reliance on brand-name biologicals like Humira undermines long-term sustainability and innovation in biosimilar development.
By March 2024, FDA has approved 49 biosimilars, including 10 biosimilar versions of adalimumab, see Table 1, three with interchangeable status. Alvotech and Teva’s Simlandi, Pfizer’s Abrilada and Boehringer Ingelheim’s Cyltezo [1, 2].
Related articles
CVS Caremark removes Humira in the US and Sandoz launches Hyrimoz in Europe
US PBMs add multiple Humira biosimilars to formularies
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Apr 16]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves interchangeable adalimumab biosimilar Simlandi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Apr 16]. Available from: www.gabionline.net/biosimilars/news/fda-approves-interchangeable-adalimumab-biosimilar-simlandi
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