Biosimilars

Panelists discuss how stakeholders can enhance biosimilar uptake through coordinated efforts in financial alignment, patient-centric pricing, professional education, simplified administrative processes, and collaborative data exchange.

Panelists discuss how health care professionals have varying confidence in biosimilars, driven by concerns about efficacy, safety, and interchangeability. Increased education, real-world evidence, professional engagement, transparent regulations, and comprehensive outcome data can help build trust in these alternative biologic treatments.

Panelists discuss how biosimilars are gaining traction through targeted education, cost-effectiveness analysis, and rigorous clinical validation, with providers increasingly integrating these alternatives by addressing knowledge barriers and demonstrating comparable therapeutic performance.

Panelists discuss how biosimilar adoption requires multifaceted organizational readiness, involving strategic infrastructure reconfiguration, comprehensive stakeholder education, rigorous clinical and economic evaluation frameworks, and adaptable operational processes to ensure seamless integration and optimization of health care delivery.

Panelists discuss how private label agreements facilitate biosimilar market entry by allowing manufacturers to collaborate on branding, distribution, and market access, ultimately expanding treatment options and potentially reducing health care costs.

Panelists discuss how employers optimize biosimilar uptake through strategic formulary design, financial incentives, and provider education, enabling health care systems to achieve substantial cost savings while maintaining high-quality patient care.

Panelists discuss how biosimilars have significantly reduced health care costs in the US, with health care systems experiencing significant savings across various therapeutic areas. These cost reductions improve treatment affordability and patient access, with potential cumulative savings in 2025.

Avtozma, the third biosimilar to Actemra, has received FDA approval for multiple inflammatory diseases and COVID-19, potentially expanding treatment access for patients.

The design of the Enhancing Oncology Model (EOM) was a perfect fit for Minnesota Oncology.

An ustekinumab biosimilar to Stelara launched in France, completing its rollout across 5 major European markets and paving the way for its US launch.

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.

Over time, biosimilars are gaining traction in the US and becoming preferred products, explained James D. Chambers, PhD, of Tufts Medical Center.

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.

The US could start catching up to Europe on biosimilars if the FDA removed the need for switching studies to be granted interchangeability.

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.