Biosimilars

Samsung Bioepis' Q1 2025 report shows oncology, ophthalmology, and pegfilgrastim biosimilars have gained significant market share, while immunology, filgrastim, epoetin alfa, and insulin glargine biosimilars have grown more slowly.

Earlier patent litigation can be reformed to reflect similar success across Europe, resulting in accelerated US biosimilar market entry.

The pharmaceutical landscape enters 2025 with a mix of challenges and opportunities, with the potential to shape the future of drug access and affordability for patients across the nation.

The top 5 biosimilar articles touch on the growing biosimilar landscape, including recent FDA approvals, patent disputes, cost-saving potential, and challenges in market entry.

In 2024, multiple drugs received complete response letters (CRLs), sometimes unrelated to the safety and efficacy of the drug, but patients with schizophrenia gained the first new treatment with a new mechanism of action in decades.

The FDA granted approval to Steqeyma (ustekinumab-stba) for inflammatory conditions, making it the seventh biosimilar to reference Stelara after a year of multiple ustekinumab biosimilar approvals.

Significant uptake of rituximab biosimilars in Medicare and Medicaid occurred within the first 4 years of marketing in the US.

Recent discussions at an Institute for Value-Based Medicine event highlighted the significant potential of biosimilars in reshaping the health care landscape, despite facing considerable barriers to adoption.

Panelists proposed policy solutions to ensure long-term sustainability of infused biosimilars amid current challenges, including average sales price erosion and reimbursement issues.

The approval of Yesintek (ustekinumab-kfce), the sixth biosimilar to reference Stelara, will be used to treat patients with various immunology conditions, including psoriatic arthritis and inflammatory bowel disease.

Global Biosimilars Week discussed issues in biosimilar adoption and called for reforms to streamline processes, foster competition, and increase biosimilar access for patients.

Financial incentives provided to hospitals in Japan led to a significant increase in biosimilar oncology drug prescriptions.

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work to address drug shortages while emphasizing safety, efficacy, and public trust.

Biosimilar aflibercept (P041) demonstrated comparable safety and efficacy to the originator aflibercept (Eylea) in treating patients with retinal conditions like neovascular age-related macular degeneration (nAMD).

A panel of industry experts discussed the complexities of biosimilars and interchangeability, emphasizing the challenges in adoption, the need for regulatory and legislative solutions, and the importance of education to combat misinformation.

Biosimilars offer significant cost-saving potential while expanding patient access, particularly in oncology and immunology.

Adalimumab biosimilar market shares have steadily increased, but challenges remain due to pricing strategies and limited government support, according to the Samsung Bioepis report.

Imuldosa (ustekinumab-srlf) is the fifth ustekinumab biosimilar referencing Stelara to receive regulatory approval in the US.

Blue Shield of California will offer an adalimumab biosimilar at a price that is 75% less than the reference product Humira for the monthly dose.

Otulfi from Formycon and Fresenius Kabi was approved simultaneously in the US and the European Union. In the US, it will launch in February 2025.

A French study found that follitropin alfa, a biosimilar fertility drug, is more cost-effective compared with its originator, leading to potential savings for both patients and the health care system.

Out-of-pocket costs for biosimilars and generics are still high for patients despite these drugs leading to estimated savings of $445 billion in 2023.

The rates of discontinuation due to inefficacy or adverse events for biosimilars and originators of etanercept and adalimumab were similar, according to an analysis of a prospective registry.

Celltrion's adalimumab-aaty biosimilar is now accessible for all Costco members, while Amgen sues Samsung Bioepis over the latter’s denosumab biosimilar candidate, and GlycoNex progresses its denosumab biosimilar SPD8 to phase 3 trials.

Delayed biosimilar uptake in the US is driven by payer, provider, and patient barriers, but targeted interventions can help boost utilization and savings.

This article first appeared on The Center for Biosimilars®.

The FDA approved Sandoz’ Enzeevu, the fourth aflibercept biosimilar to be approved for Americans with age-related macular degeneration and other retinal eye diseases.

The FDA approved the first 2 biosimilars referencing aflibercept (Eylea). However, patent litigation has left it unclear when the biosimilars will come to market.

Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.

Patients with radiographic axial spondyloarthritis (ax-SpA) and a high risk of radiographic progression had similar low progression on both secukinumab and an adalimumab biosimilar.