Biosimilars Gastroenterology Roundup: January 2024

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.