In addition to the several reports that have come out quantifying how the gastroenterology biosimilar market is progressing, January marks the 1-year anniversary of adalimumab biosimilar competition in the US.
In addition to the several reports that have come out quantifying how the gastroenterology biosimilar market is progressing, January marks the 1-year anniversary of adalimumab biosimilar competition in the United States.
1-Year of Adalimumab Biosimilars
The end of January represents the 1-year anniversary of the first US launch for an adalimumab biosimilar (Amgevita). Since then, 1 biosimilar for Humira (reference adalimumab) received approval, another received an interchangeability designation, and 8 more have launched. Additionally, market dynamics have begun to take shape as companies experiment with dual-pricing strategies to tempt payers and pharmacy benefit managers into covering their products. However, uptake remains low at the 1-year mark.
Ustekinumab Updates
The biggest update for ustekinumab biosimilars is the European Medicines Agency approval of Uzpruvo as the first biosimilar to reference Stelara (originator ustekinumab). The product was approved to treat Crohn disease, psoriatic arthritis, and plaque psoriasis. The biosimilar was developed by Alvotech and will be marketed by STADA Arzneimittel.
Additionally, the FDA accepted a biologic license application for DMB-3115, an ustekinumab biosimilar developed by Accord Biopharma. If successful, it would be the second ustekinumab biosimilar to receive approval in the US.
In legal news, CareFirst BlueCross BlueShield has filed a lawsuit against the reference manufacturer Johnson & Johnson (J&J), accusing them of scheming to create a monopoly beyond the legitimate patent exclusivity period, potentially breaking J&J's ustekinumab monopoly if successful and allowing earlier access to biosimilar versions for plaque psoriasis and psoriatic arthritis. Currently, settlement agreements have postponed the US arrival of ustekinumab biosimilars on the market from late 2023 to early 2025.
Market Insights
IQVIA came out with its Global Use of Medicines report and a white paper on the impact of biosimilar competition in Europe. The white paper highlighted persistent challenges in achieving sustained access and savings growth, prompting a call for increased attention to policies that foster a sustainable market and ensure a robust pipeline. The report underscored essential factors for a flourishing biosimilar ecosystem, encompassing savings, pricing, accessibility, strategic considerations, and competitive dynamics.
The latest Global Use of Medicines report projected that losses for original products will increase from $111 billion to $192 billion by the conclusion of 2028, attributable to the introduction of new biosimilar and generic medicines in the market, particularly in the gastroenterology and immunology markets. The annual report aims to provide supporting evidence for discussions on the value, cost, and role of medicines over the next 5 years in health care spending.
Samsung Bioepis' Biosimilar Market Report for the first quarter of 2024 chronicled major market trends, finding that, on average, biosimilars obtained a 53% market share in the first 3 years after the initial launch. It also highlighted treatment spaces with quicker uptake than others and emphasized missed opportunities for savings. The report also examined the 1-year experience of adalimumab biosimilar competition in the US, finding that these products have only obtained 2% market share by the end of 2023.
Clinical Results
The PROPER trial in Europe demonstrated the effectiveness and safety of transitioning from Humira to the SB5 biosimilar in treating inflammatory diseases, validating SB5 as a cost-efficient alternative to adalimumab. A cohort of 955 participants with various immune-mediated inflammatory diseases shifted from the originator to the SB5 biosimilar. The real-world application of SB5 for patients with immune-mediated inflammatory diseases showed efficacy and tolerance during the transition. However, the authors highlighted the need for special consideration for female patients, as they may be more susceptible to discontinuation compared with their male counterparts.
Lastly, a review of postapproval pharmacovigilance data for 8 Sandoz biosimilars, encompassing over 1.3 billion patient days of exposure, concluded that these biosimilars can be used as safely as their respective reference biologics. However, despite demonstrated efficacy and safety, lingering concerns persist among health care providers, patients, and policy experts about the long-term safety of biosimilars, emphasizing the importance of postapproval safety data for real-world use.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During Its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
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.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Biosimilars Gastroenterology Roundup for January 2024—Podcast Edition
February 4th 2024On this episode of Not So Different, we reminisce on all the major gastroenterology news from January, which brought several reports quantifying how the gastroenterology biosimilar market is progressing and marked the 1-year anniversary of adalimumab biosimilar competition in the US.
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.